SimplyStrong

GUDID 00877972006091

GENICON, INC.

Tissue extraction bag
Primary Device ID00877972006091
NIH Device Record Keyb5d536ea-334b-428f-bba6-fa6d2771ba87
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplyStrong
Version Model Number550-000-012
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
GS100877972006091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, 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 Date2019-10-23
Device Publish Date2017-05-05

On-Brand Devices [SimplyStrong]

00877972006138550-000-017
00877972006114550-000-013
00877972006091550-000-012
00877972006077550-000-011
00877972006053550-000-009
00877972005933550-000-010

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