Cap

GUDID 00877972000419

GENICON, INC.

Laparoscopic access cannula seal reducer
Primary Device ID00877972000419
NIH Device Record Key7179dd3e-8838-4548-8227-d8e769e9db58
Commercial Distribution StatusIn Commercial Distribution
Brand NameCap
Version Model Number100-010-744
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
GS100877972000419 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-05-05

On-Brand Devices [Cap]

00877972000419100-010-744
00877972000402100-005-631

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