Identity
- Trade Name
- exofin Mastic, 1 oz. FDA UDI
- Generic Name
- Skin-cover sealant FDA UDI
- Device Name
- Class 1 FDA UDI
- Model / Reference
- EM81512 FDA UDI
- Description
- Class 1 FDA UDI
Identifiers
- Catalog Number
- EM81512 FDA UDI
- Primary DI / UDI-DI
- 00854137001702 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Skin-cover sealant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
exofin Mastic, 1 oz. by Chemence Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Chemence Medical Inc.
Sources (1)
- FDA UDI 37eb3f24-bf7a-4525-8678-5632ea6c0198 36 fields · synced Sep 18, 2026