Abdominal specula

GUDID 04059082014944

SOPRO-COMEG GmbH

Vaginal speculum, reusable
Primary Device ID04059082014944
NIH Device Record Key5e8ec1ae-d016-467c-ad9b-945bc6cdd73f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbdominal specula
Version Model Number392 996 002
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
GS104059082014944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082014944]

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

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

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