Carter-Thomason CloseSure System Pilot Guides

GUDID 20888937002991

Contents: One 5mm Pilot Guide and one 10/12mm Pilot Guide

Coopersurgical, Inc.

Laparoscopic wound closure thread
Primary Device ID20888937002991
NIH Device Record Key45383264-1b78-4c5c-a9a3-e02b964a2049
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-Thomason CloseSure System Pilot Guides
Version Model NumberPG-5/10
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120888937002991 [Package]
Contains: 60888937002999
Package: [5 Units]
In Commercial Distribution
GS160888937002999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-19

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