ENDOSCOPE STERILIZATION &

GUDID 00821925019133

Gyrus Acmi, Inc.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00821925019133
NIH Device Record Key65b610c6-96f3-4162-ac15-ae295adbc280
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOSCOPE STERILIZATION &
Version Model Number230871
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
GS100821925019133 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


[00821925019133]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-10
Device Publish Date2018-09-11

Devices Manufactured by Gyrus Acmi, Inc.

00810008180983 - nCare2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
00810008180990 - nCare2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
00810008180501 - nCare2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
00810008180921 - nCare2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
00810008180952 - nCare2023-09-25 nCare, SNGL,DRCT SDI,DICOM
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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