Carter-Thomason (REGARD Distributed)

GUDID 20888937027031

Carter-Thomason CloseSure System, 1 Box of 5 Systems Distributed under REGARD Brand

Coopersurgical, Inc.

Laparoscopic wound closure thread
Primary Device ID20888937027031
NIH Device Record Key839a2799-b368-4db5-87e4-6552405a9549
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-Thomason (REGARD Distributed)
Version Model Number75926
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
GS120888937027031 [Package]
Contains: 60888937027039
Package: Box [5 Units]
In Commercial Distribution
GS160888937027039 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-06
Device Publish Date2022-09-28

On-Brand Devices [Carter-Thomason (REGARD Distributed)]

20888937027031Carter-Thomason CloseSure System, 1 Box of 5 Systems Distributed under REGARD Brand
00888937027044SG Suture Passer with SureGrasp Technology. Distributed under REGARD Brand.

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