FIBER OPTIC LIGHT CABLE 8' LONG 4.0 MM DIAMETER

GUDID 00821925019935

Gyrus Acmi, Inc.

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Primary Device ID00821925019935
NIH Device Record Key369a784d-dbd0-48c2-b35c-5be42c38584a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIBER OPTIC LIGHT CABLE 8' LONG 4.0 MM DIAMETER
Version Model Number230559
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 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
GS100821925019935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCMENDOSCOPE, RIGID

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


[00821925019935]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-09