Amniotic
AmnioText
AmnioText volume-based product reference
HCPCS Q4245 reference
- Format
- Volume-based reference
- Access
- Documentation review
AMNIOTIC PRODUCT PROFILE
AmnioText Patch
Dual-layer dehydrated amniotic membrane patch
Human amniotic membrane. Product identity and documentation for professional review.
AMNIOTIC
Dual-layer dehydrated amniotic membrane patch
A dehydrated amnion / amnion membrane, described by the manufacturer as sterile. Ten sheet configurations are listed in the product brochure. This patch is distinct from the AmnioText per-cc reference; confirm current labeling and availability for the selected item.
- Dual-layer amnion / amnion; Fibroblast Layer Out
- Dehydrated membrane
- Room-temperature storage per manufacturer; follow current package instructions
- Material / configuration
- Dual-layer amnion / amnion; Fibroblast Layer Out
- Format
- Dehydrated membrane
- Storage & handling
- Room-temperature storage per manufacturer; follow current package instructions
- Manufacturer
- Regenative Labs
- Shelf life
- Manufacturer lists 5 years; the supplied package expiry controls
- HCPCS reference
- Q4247 · Per square centimeter
Patch area and billable units are separate determinations. Confirm the current descriptor, payer policy, and documentation for the actual service.
CMS code referenceThe linked PACE-specific list is used here for code identity only, not to determine coverage under other programs.
PRODUCT CONFIGURATIONS
Sizes & item codes.
| Configuration | Item code | Details | Selection |
|---|---|---|---|
| 1 × 1 cm | APF2-11 | 1 cm² | |
| 2 × 2 cm | APF2-22 | 4 cm² | |
| 2 × 3 cm | APF2-23 | 6 cm² | |
| 3 × 3 cm | APF2-33 | 9 cm² | |
| 3 × 4 cm | APF2-34 | 12 cm² | |
| 4 × 4 cm | APF2-44 | 16 cm² | |
| 4 × 6 cm | APF2-46 | 24 cm² | |
| 4 × 8 cm | APF2-48 | 32 cm² | |
| 8 × 8 cm | APF2-88 | 64 cm² | |
| 10 × 10 cm | APF2-10 | 100 cm² |
DOCUMENTATION REQUEST
Item code APF2-11
Request documentationInformation request only. No clinical use is authorized by this profile.
Dimensions and geometric areas describe product formats, not billable units. Use current source-issued labeling and the confirmed item code before ordering.
PRODUCT DOCUMENTATION
Documents & source information.
Specifications, instructions, and evidence belong with the exact product your team is reviewing.
Product source informationReview the source's current product description and documentationCurrent labeling & instructionsAvailable on request / exact product and revisionSpecifications & source questionsAvailable on request / composition, handling, packaging, and traceabilityRegenerative medicine informationFDA information on unapproved regenerative therapies
REQUEST A PRODUCT FILE
Which documents do you need?
Your selected configuration stays with your request.
AmnioText PatchDehydrated membrane
Document availability and the responsible source are confirmed by the team. Selecting a document does not certify the product or establish approval.
Current labeling & instructions, Composition & specifications, Source & regulatory status
BEYOND THE SPECIFICATION
Understand the format.
An amniotic membrane specification should distinguish tissue layers, processing, hydration state, dimensions, and orientation. Similar layer names do not make different products interchangeable.
Materials & formats01
What distinguishes this profile
The manufacturer describes two amnion layers and lists Fibroblast Layer Out as the construction. This is not a bedside placement instruction; follow the current instructions for the exact package. The Q4247 patch is distinct from AmnioText Q4245.
02
Read the numbers correctly
HCPCS Q4247: Per square centimeter. Patch area and billable units are separate determinations. Confirm the current descriptor, payer policy, and documentation for the actual service.
03
Questions for the product file
- Which revision of the labeling and instructions applies to this exact item?
- What preparation, handling, and package-expiry requirements apply?
- Which documents accompany the lot, shipment, or device, and who handles a product concern?
A FEW MORE DETAILS
Questions about AmnioText Patch
CONTINUE EXPLORING
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- Format
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- Configurations
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