BiSurge

GUDID 00877972006619

GENICON, INC.

Laparoscopic access cannula, single-use
Primary Device ID00877972006619
NIH Device Record Keyba8d472a-5b16-4a22-a710-4eb8726feddb
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiSurge
Version Model Number620-163-920
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 Kittrue
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
GS100877972006619 [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 Number5
Public Version Date2020-01-09
Device Publish Date2017-10-11

On-Brand Devices [BiSurge]

00877972006671628-163-950
00877972006657628-163-920
00877972006633620-163-950
00877972006619620-163-920
00877972006336633-105-950
00877972006312633-105-920
00877972006299633-005-950
00877972006275633-005-920

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