Bronchoscope

GUDID 04059082003955

SOPRO-COMEG GmbH

Rigid bronchoscope
Primary Device ID04059082003955
NIH Device Record Key4a042645-d1a2-409d-af6c-3b33296d8e03
Commercial Distribution StatusIn Commercial Distribution
Brand NameBronchoscope
Version Model Number164 053 630BC001
Company DUNS507185952
Company NameSOPRO-COMEG GmbH
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104059082003955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


[04059082003955]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [Bronchoscope]

04059082029740164 055 002
04059082029733164 055 000
04059082029726164 053 630
04059082029719164 044 510
04059082003986164 055 002BC001
04059082003962164 055 000BC001
04059082003955164 053 630BC001
04059082003948164 044 510BC001

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