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C2 CryoBalloon EndoGrip

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
C2 CryoBalloon EndoGrip FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
EndoGrip FDA UDI
Model / Reference
FG-1040 FDA UDI
Description
EndoGrip FDA UDI

Identifiers

Primary DI / UDI-DI
00854924006408 FDA UDI
510(k) Number
K193036 FDA UDI
FDA Product Code
OCX FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: General cryosurgical system, cryogen gas, mechanical

C2 CryoBalloon EndoGrip by PENTAX of America, 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
PENTAX of America, Inc.

Sources (1)

  • FDA UDI d8638dfc-11f6-4475-b831-af09861fbe2e 34 fields · synced May 29, 2026