Handle for sinuscope

GUDID 04059082029641

SOPRO-COMEG GmbH

Endoscope sheath, reusable
Primary Device ID04059082029641
NIH Device Record Key6f474a48-cdaa-4556-ac89-078f294307e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandle for sinuscope
Version Model Number191 400 000
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 Numbertrue
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
GS104059082029641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (flexible or rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082029641]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2018-03-20

On-Brand Devices [Handle for sinuscope]

04059082029658191 400 001
04059082029641191 400 000
04059082006949191 400 001BC
04059082006932191 400 000BC

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