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exofin Fusion Skin Closure System SourceMark, 60cm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- exofin Fusion Skin Closure System SourceMark, 60cm FDA UDI
- Generic Name
- Wound closure set, topical FDA UDI
- Model / Reference
- M1244 FDA UDI
Identifiers
- Catalog Number
- M1244 FDA UDI
- Primary DI / UDI-DI
- 00854137001757 FDA UDI
- 510(k) Number
- K171442 FDA UDI
- FDA Product Code
- OMD FDA UDI
- GMDN Term
- Wound closure set, topical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4011 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 closure set, topical
exofin Fusion Skin Closure System SourceMark, 60cm by Chemence Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound closure set, topical.
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- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
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- DERMABOND PRINEO — Ethicon Inc. · Class II
- DERMABOND PRINEO — Ethicon Inc. · Class II
Cleared under the same submission
K171442 also covers:
- Exofin Fusion Skin Closure System — CHEMENCE MEDICAL INC.
- Exofin Fusion Skin Closure System SourceMark, 6cm — CHEMENCE MEDICAL INC.
- Exofin Fusion Skin Closure System, 6cm — CHEMENCE MEDICAL INC.
- exofin Fusion Skin Closure System, 30cm — CHEMENCE MEDICAL INC.
- exofin Fusion Skin Closure System, 60cm — CHEMENCE MEDICAL 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 II | Pending data |
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Manufacturer
- Manufacturer
- Chemence Medical Inc.
Sources (1)
- FDA UDI 171480ed-041e-4776-9b40-e661b443ed27 35 fields · synced Sep 18, 2026