Carter-Thomason SG

GUDID 20888937002939

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

Coopersurgical, Inc.

Laparoscopic wound closure thread
Primary Device ID20888937002939
NIH Device Record Key79f66f8e-8a4e-4a33-a50e-dd355980f2f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarter-Thomason SG
Version Model NumberCTI-1015SG
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
GS120888937002939 [Package]
Contains: 60888937002937
Package: [5 Units]
In Commercial Distribution
GS160888937002937 [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 Date2016-08-18

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60888937027176 - ERPeak2024-04-18 IVD Sample kit
60888937027183 - ERPeak2024-04-18 IVD Sample kit
60888937027190 - ERPeak2024-04-18 IVD Sample kit
60888937027206 - ERPeak2024-04-18 IVD Sample kit
00888937026870 - Mara Console2024-03-21 Mara Console- Endometrial Ablation
00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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