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Histofreezer

FDA UDI

Class II (US FDA UDI)

by OraSure Technologies, Inc.

Identity

Trade Name
Histofreezer FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
Histofreezer Kit, U.S., 60MC2 +10 FDA UDI
Model / Reference
1001-0375 FDA UDI
Description
Histofreezer Kit, U.S., 60MC2 +10 FDA UDI

Identifiers

Primary DI / UDI-DI
00608337000559 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

Category: General cryosurgical system, cryogen gas, mechanical

Histofreezer by OraSure Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OraSure Technologies, Inc.

Sources (1)

  • FDA UDI 1b955f5d-a60b-455c-8a99-92b5ed70592d 35 fields · synced Jun 9, 2026