Carter-thomason CloseSure System XL

GUDID 20888937002960

Contents: One Suture Passer XL, one 10/12mm Pilot Guide XL and one 15mm Pilot Guide XL

Coopersurgical, Inc.

Laparoscopic wound closure thread
Primary Device ID20888937002960
NIH Device Record Key379ad16d-30c8-4da7-a1fe-560b57719ac3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-thomason CloseSure System XL
Version Model NumberCTXL
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
GS120888937002960 [Package]
Contains: 60888937002968
Package: [3 Units]
In Commercial Distribution
GS160888937002968 [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 Number4
Public Version Date2018-10-12
Device Publish Date2016-08-18

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Trademark Results [Carter-thomason CloseSure System XL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARTER-THOMASON CLOSESURE SYSTEM XL
CARTER-THOMASON CLOSESURE SYSTEM XL
78695771 3129427 Live/Registered
COOPERSURGICAL, INC.
2005-08-18

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