Identity
- Trade Name
- InnovaBurn FDA UDI
- Generic Name
- Wound compression dressing FDA UDI
- Device Name
- 10cm x 20cm Placental ECM FDA UDI
- Model / Reference
- IMB-1020-01 FDA UDI
- Description
- 10cm x 20cm Placental ECM FDA UDI
Identifiers
- Catalog Number
- IMB-1020-01 FDA UDI
- Primary DI / UDI-DI
- 00850002643305 FDA UDI
- 510(k) Number
- K213716 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- Wound compression dressing FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound compression dressing
InnovaBurn by Triad Life Sciences, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213716 also covers:
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
- InnovaBurn — Triad Life Sciences, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Triad Life Sciences, Inc.
Sources (1)
- FDA UDI ad8c9a68-9ac5-41e3-bc13-9a671f124d1d 35 fields · synced May 30, 2026