Flexible Cystoscopic Biopsy Forceps Double-Action, Stem Only 10 Fr, (

GUDID 00821925004061

Gyrus Acmi, Inc.

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Primary Device ID00821925004061
NIH Device Record Keyaa1194c5-cee3-4153-b2b9-32dc0cd5581a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Cystoscopic Biopsy Forceps Double-Action, Stem Only 10 Fr, (
Version Model Number331S10
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925004061 [Primary]

FDA Product Code

KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


[00821925004061]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-12
Device Publish Date2018-09-11

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00810008180969 - nCare2023-09-25 nCare, SNGL, ELA, DICOM
00810008180976 - nCare2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
00821925036406 - USA Elite2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)

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