Identity
- Trade Name
- InnovaBurn FDA UDI
- Generic Name
- Wound compression dressing FDA UDI
- Device Name
- 15cm x 20cm Placental ECM FDA UDI
- Model / Reference
- IMB-1520-01 FDA UDI
- Description
- 15cm x 20cm Placental ECM FDA UDI
Identifiers
- Catalog Number
- IMB-1520-01 FDA UDI
- Primary DI / UDI-DI
- 00850002643312 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
Similar devices
Also classified as Wound compression dressing.
- EAR DRESSING, ADULT — Oto-Med, Inc. · Class I
- Neptune Plus Calcium Alginate Pad — Tz Medical, Inc. · U
- HEAD & NECK PRESSURE DRESSING — Oto-Med, Inc. · Class I
- E Neptune Hemostasis Pad — Tz Medical, Inc. · U
- OmniTrustTM — OMNI INTERNATIONAL CORP. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Neptune Comfort Band — Tz Medical, Inc. · U
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Triad Life Sciences, Inc.
Sources (1)
- FDA UDI e32b8ef6-da22-42cb-bd4a-7ca5c93b0965 35 fields · synced May 30, 2026