FDA UDI
In Commercial Distribution
🇺🇸 United States
Endoform™ Natural Restorative Bioscaffold
DI: 09421906017236
·
Model: 529316
·
AROA BIOSURGERY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Endoform™ Natural Restorative Bioscaffold
- Primary DI
- 09421906017236
- Version / Model
- 529316
- Company Name
- AROA BIOSURGERY LIMITED
- Labeler DUNS
- 594540572
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-20
- Public Version
- 3
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- a3583c07-3248-4295-8e77-7dfa7228ca4c
Device Description
Endoform™ Natural is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with wound exudate or sterile saline, Endoform Natural transforms into a soft conforming sheet, which is incorporated into the wound over time.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Dressing, Wound, Collagen | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Animal-derived wound matrix dressing | A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09421906017342 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 09421906017236 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092096 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 x 22 cm - 6 x 8.5" |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Endoform Natural should be stored at room temperature in a clean and dry area.