Adaptable tube

GUDID 04059082029252

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082029252
NIH Device Record Key42166dc1-e775-4702-850c-6d1ade157997
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdaptable tube
Version Model Number191 400 110
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
GS104059082029252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082029252]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-11
Device Publish Date2016-12-19

Devices Manufactured by SOPRO-COMEG GmbH

04059082003559 - Thoracoscope2019-11-08
04059082003757 - Hysteroscope2019-11-08
04059082003764 - Hysteroscope2019-11-08
04059082003795 - Hysteroscope2019-11-08
04059082003818 - Hysteroscope2019-11-08
04059082003856 - Hysteroscope2019-11-08
04059082003870 - Hysteroscope2019-11-08
04059082003894 - Hysteroscope2019-11-08

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