C2 CryoBalloon Nitroclip

GUDID 04961333248445

NitroClip

PENTAX OF AMERICA, INC.

General cryosurgical system, cryogen gas, mechanical
Primary Device ID04961333248445
NIH Device Record Keyd8cd5847-b2b0-4e3c-a651-b6866783a3cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2 CryoBalloon Nitroclip
Version Model NumberFG-1050
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333248445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

Devices Manufactured by PENTAX OF AMERICA, INC.

04961333255313 - C2 CryoBalloon2024-09-20
04961333255320 - C2 CryoBalloon2024-09-20
04961333254309 - MULTI-SPEECH2023-09-04 Multi-Speech Microphone, Condensor
04961333248117 - Pentax of America2022-11-14 Capture Module
04961333248445 - C2 CryoBalloon Nitroclip2020-08-17NitroClip
04961333248445 - C2 CryoBalloon Nitroclip2020-08-17 NitroClip
00854924006408 - C2 CryoBalloon EndoGrip2020-08-06 EndoGrip
04961333248001 - ENDOPRO REVIEW WORKSTATION2020-04-03 ENDOPRO REVIEW WORKSTATION
04961333248018 - ENDOPRO NETWORK CAPTURE WORKSTATION2020-04-03 ENDOPRO CAPTURE WORKSTATION, NETWORK

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