GeniPalm

GUDID 00877972005094

GENICON, INC.

Laparoscopic access cannula, single-use
Primary Device ID00877972005094
NIH Device Record Key3a2398b5-121d-482f-9f18-faa13d212f79
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeniPalm
Version Model Number100-105-051
Company DUNS079805400
Company NameGENICON, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100877972005094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEACannula, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2017-05-05

On-Brand Devices [GeniPalm]

00877972005254100-005-150
00877972005131100-112-151
00877972005117100-105-052
00877972005094100-105-051
00877972005070100-010-150
00877972005056100-005-052
00877972005032100-005-051
00877972005018100-005-050
00877972004998100-012-151
00877972004974100-012-150
00877972004936100-105-152
00877972004912100-005-152
00877972004899100-110-151
00877972004875100-105-151
00877972004851100-010-151
00877972004837100-005-151
00877972004462100-108-151

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