Identity
- Trade Name
- MEDI-FRIG FDA UDI
- Generic Name
- Cryogenic spray, dental FDA UDI
- Device Name
- MEDI-FRIG, ONE CANISTER (280G) W STRAW FDA UDI
- Model / Reference
- H11B FDA UDI
- Description
- MEDI-FRIG, ONE CANISTER (280G) W STRAW FDA UDI
Identifiers
- Catalog Number
- H11B FDA UDI
- Primary DI / UDI-DI
- 00841494103866 FDA UDI
- 510(k) Number
- K954703 FDA UDI
- FDA Product Code
- JEH FDA UDI
- GMDN Term
- Cryogenic spray, dental FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cryogenic spray, dental
Medi-Frig by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cryogenic spray, dental.
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Dental City — ICP, INC. · Class II
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class II
Cleared under the same submission
K954703 also covers:
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
- Cynosure, LLC
Sources (1)
- FDA UDI d02462f4-85fe-466f-81ca-d60ccca303db 35 fields · synced May 30, 2026