Carter-Thomason (REGARD Distributed)

GUDID 00888937027044

SG Suture Passer with SureGrasp Technology. Distributed under REGARD Brand.

Coopersurgical, Inc.

Suturing unit, single-use
Primary Device ID00888937027044
NIH Device Record Key7826bc83-b88d-4fc4-b2c3-7bfb5cf29f58
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-Thomason (REGARD Distributed)
Version Model Number534545
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 Kitfalse
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
GS100888937027044 [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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