ACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)

GUDID 00821925001220

Gyrus Acmi, Inc.

Endoscopic biopsy valve, sterile
Primary Device ID00821925001220
NIH Device Record Key5dc57484-a9b9-4251-b7cb-1f212082aaeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)
Version Model NumberCS-W7S
Company DUNS007198742
Company NameGyrus Acmi, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925001220 [Package]
Contains: 00821925036352
Package: [6 Units]
In Commercial Distribution
GS100821925036352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope and accessories, flexible/rigid

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 Date2016-10-13

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