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Cool Renewal

FDA UDI

Class II (US FDA UDI)

by Cool Renewal, LLC

Identity

Trade Name
COOL RENEWAL FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
COOL RENEWAL SINGLE REPLACEMENT CANISTER- 170mL FDA UDI
Model / Reference
CR-RC1 FDA UDI
Description
COOL RENEWAL SINGLE REPLACEMENT CANISTER- 170mL FDA UDI

Identifiers

Catalog Number
CR-RC1 FDA UDI
Primary DI / UDI-DI
00860441000423 FDA UDI
510(k) Number
K161296 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 170 Milliliter FDA UDI

Category: General cryosurgical system, cryogen gas, mechanical

Cool Renewal by Cool Renewal, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, mechanical.

Cleared under the same submission

K161296 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cool Renewal, LLC

Sources (1)

  • FDA UDI cc27174c-667e-4a0e-8e09-81f5e24be6b3 38 fields · synced May 30, 2026