Sinuscope

GUDID 04059082003207

SOPRO-COMEG GmbH

Rigid sinoscope
Primary Device ID04059082003207
NIH Device Record Key3618a861-2ee8-4d96-9124-25a9d188df58
Commercial Distribution StatusIn Commercial Distribution
Brand NameSinuscope
Version Model Number161 401 813BC001
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
GS104059082003207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

Moist Heat or Steam Sterilization


[04059082003207]

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 [Sinuscope]

04059082029597161 401 825
04059082029580161 401 820
04059082029573161 401 815
04059082029566161 401 813
04059082029559161 401 812
04059082029542161 401 810
04059082029535161 401 805
04059082029528161 401 803
04059082029511161 401 802
04059082029504161 401 800
04059082029498161 271 785
04059082029481161 271 782
04059082029474161 271 780
04059082029467161 271 765
04059082029450161 271 762
04059082029443161 271 760
04059082003245161 401 825BC001
04059082003221161 401 820BC001
04059082003214161 401 815BC001
04059082003207161 401 813BC001
04059082003191161 401 812BC001
04059082003184161 401 810BC001
04059082003160161 401 805BC001
04059082003153161 401 803BC001
04059082003139161 401 802BC001
04059082003115161 401 800BC001
04059082002965161 271 785BC001
04059082002941161 271 782BC001
04059082002927161 271 780BC001
04059082002859161 271 765BC001
04059082002835161 271 762BC001
04059082002811161 271 760BC001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.