FDA UDI
In Commercial Distribution
🇺🇸 United States
Endoform Natural Dermal Template
DI: 09421904065475
·
Model: 529313
·
AROA BIOSURGERY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Endoform Natural Dermal Template
- Primary DI
- 09421904065475
- Version / Model
- 529313
- Catalog Number
- 529313
- Company Name
- AROA BIOSURGERY LIMITED
- Labeler DUNS
- 594540572
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-31
- Public Version
- 5
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- c475dd8a-0580-4cca-8d62-d0b0a83c804e
Device Description
Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | Collagen wound matrix dressing | A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09421904065635 | GS1 | SHIPPER | 50 | In Commercial Distribution | |
| Package | 09421904065536 | GS1 | CARTON | 10 | In Commercial Distribution | |
| Primary | 09421904065475 | GS1 |
Customer Contacts
- Phone
- 877-627-6224
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092096 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 12.7 | Centimeter | |
| Length | 10 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- clean and dry area, away from direct light