Identity
- Trade Name
- FREEZPOINT™ FDA UDI
- Generic Name
- Cryogenic spray, cutaneous FDA UDI
- Device Name
- FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 16G FDA UDI
- Model / Reference
- CRY16 FDA UDI
- Description
- FREEZE POINT™ MULTI-USE DISPOSABLE CRYOSURGICAL DEVICE - 16G FDA UDI
Identifiers
- Catalog Number
- CRY16 FDA UDI
- Primary DI / UDI-DI
- 00850077006012 FDA UDI
- 510(k) Number
- K102006 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- Cryogenic spray, cutaneous FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 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
Yes
FDA UDI
Category: Cryogenic spray, cutaneous
Freezpoint™ by Bovie Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryogenic spray, cutaneous.
- CryoLab Medical — CRYOCONCEPTS, LP · Class II
- CryOmega — CRYOCONCEPTS, LP · Class II
- Equate — Walmart Stores · Class II
- CryoClear — CRYOCONCEPTS, LP · Class II
- Premier CryOmega — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Cryo Professional — Koninklijke Utermöhlen N.V. · Class II
- Cryo Professional — Koninklijke Utermöhlen N.V. · Class II
Cleared under the same submission
K102006 also covers:
- FREEZPOINT™ — BOVIE MEDICAL CORPORATION
- CryOmega — CRYOCONCEPTS, LP
- CryOmega — CRYOCONCEPTS, LP
- CryoClear — CRYOCONCEPTS, LP
- CryoClear — CRYOCONCEPTS, LP
- Premier CryOmega — PREMIER DENTAL PRODUCTS COMPANY
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY
- Premier-CryOmega — PREMIER DENTAL PRODUCTS COMPANY
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
- Bovie Medical Corporation
Sources (1)
- FDA UDI 2cf47bf0-e735-4dd5-a4fe-8a8b392edce0 36 fields · synced Jun 8, 2026