CS-G5 Self Sealing Seal 2-5 FR (.67-1.67mm)

GUDID 00821925001183

Gyrus Acmi, Inc.

Endoscope working-channel seal
Primary Device ID00821925001183
NIH Device Record Key1decf00d-f059-4f36-a3b0-c96680e7d9dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS-G5 Self Sealing Seal 2-5 FR (.67-1.67mm)
Version Model NumberCS-G5
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
GS100821925001183 [Package]
Contains: 00821925038325
Package: [6 Units]
In Commercial Distribution
GS100821925038325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925001183]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

[00821925001183]

Moist Heat or Steam Sterilization

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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