Carter-Thomason II

GUDID 20888937002908

Carter-Thomason II Port Closure System

Coopersurgical, Inc.

Laparoscopic wound closure thread
Primary Device ID20888937002908
NIH Device Record Keya701b2c6-54c3-49ee-b97b-be4b340381cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-Thomason II
Version Model NumberCTI-1012P
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120888937002908 [Package]
Contains: 60888937002906
Package: [1 Units]
In Commercial Distribution
GS160888937002906 [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 Date2016-09-26

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