Knot guide

GUDID 04059082015415

SOPRO-COMEG GmbH

Endoscopic suturing unit, reusable
Primary Device ID04059082015415
NIH Device Record Key57f6fc6d-f55a-41ac-ad5e-d2bafdcadc3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnot guide
Version Model Number392 999 403
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
GS104059082015415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082015415]

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 [Knot guide]

04059082015439392 999 453
04059082015422392 999 450
04059082015415392 999 403
04059082015392392 999 401
04059082015385392 999 400

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