GeniClip Open Applier

GUDID 00877972004813

GENICON, INC.

Open-surgery ligation clip applier
Primary Device ID00877972004813
NIH Device Record Key94eb3f56-20ee-4fc2-8602-ef2c5c3de9d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeniClip Open Applier
Version Model Number330-005-005
Company DUNS079805400
Company NameGENICON, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100877972004813 [Primary]

FDA Product Code

HBTApplier, Hemostatic Clip

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00877972004813]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2017-05-05

On-Brand Devices [GeniClip Open Applier]

00877972004813330-005-005
00877972004806330-005-004
00877972004790330-005-003
00877972004783330-005-002
00877972004776330-005-001
00877972004769330-005-000

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