Facial closure instrument

GUDID 04059082015408

SOPRO-COMEG GmbH

Suturing needle, reusable
Primary Device ID04059082015408
NIH Device Record Keya45bb393-afb9-4fd1-b647-4a5ef87075e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFacial closure instrument
Version Model Number392 999 402
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
GS104059082015408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082015408]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
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

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