Amniotic product profile
AmnioText Patch
Dual-layer dehydrated amniotic membrane patch
Human amniotic membrane. Product identity and documentation for professional review.
Overview
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
Specifications
- Material
- Human amniotic membrane
- 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
Sizes & item codes
| Configuration | Item code | Details |
|---|---|---|
| 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 Listed in the manufacturer brochure. Confirm current availability with the source. |
| 10 × 10 cm | APF2-10 | 100 cm² |
Dimensions and geometric areas describe product formats, not billable units. Use current source-issued labeling and the confirmed item code before ordering.
Documents & source information
Specifications, instructions, and evidence belong with the exact product your team is reviewing.
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.
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.
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.
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?
Questions about AmnioText Patch
Does this profile authorize a treatment?
No. This profile is informational. It does not establish FDA approval, a permitted route of administration, or suitability for a patient.
Which instructions should our team follow?
Use the current source-issued instructions for the exact product and package. Website summaries do not replace labeling, handling instructions, or professional review.
Does this page establish coverage?
No. Product information and a billing code do not establish case-specific coverage or payment. Confirm payer requirements through the appropriate secure workflow.