Identity
- Trade Name
- bio-ConneKt FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Model / Reference
- PN-50-101 FDA UDI
Identifiers
- Catalog Number
- 1101-0303 FDA UDI
- Primary DI / UDI-DI
- 00861175000116 FDA UDI
- 510(k) Number
- K140456 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- Animal-derived wound matrix 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
No
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: Animal-derived wound matrix dressing
bio-ConneKt by Mlm Biologics, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Animal-derived wound matrix dressing.
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- HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
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Cleared under the same submission
K140456 also covers:
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- OrthoNovis Connect — Mlm Biologics, Inc.
- bio-ConneKt — Mlm Biologics, Inc.
- bio-ConneKt — Mlm Biologics, 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
- Mlm Biologics, Inc.
Sources (1)
- FDA UDI e4a2540a-535c-4d98-921f-e77dd5780fc2 34 fields · synced May 30, 2026