Identity
- Trade Name
- CryoDose H FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- CryoDose H 1 kit w/ 2 canisters, 30/ 2mm buds, 40/ 5mm buds FDA UDI
- Model / Reference
- 170375 FDA UDI
- Description
- CryoDose H 1 kit w/ 2 canisters, 30/ 2mm buds, 40/ 5mm buds FDA UDI
Identifiers
- Catalog Number
- 170375 FDA UDI
- Primary DI / UDI-DI
- 00856331006088 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 88 Milliliter FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
CryoDose H by Nuance Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nuance Medical, Llc
Sources (1)
- FDA UDI 44980a13-0a3c-4af4-bd79-acdb9f02900a 37 fields · synced May 30, 2026