Carter-Thomason - Carter-Thomason CloseSure System, 1 Box of 5 - Coopersurgical, Inc.

Duns Number:801895244

Device Description: Carter-Thomason CloseSure System, 1 Box of 5 Systems

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More Product Details

Catalog Number

-

Brand Name

Carter-Thomason

Version/Model Number

CTI-512N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K980123,K980123

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

2f01ccab-3cab-42eb-9bd7-0d8ab915de88

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20888937000096

Quantity per Package

1

Contains DI Package

60888937000094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COOPERSURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 1471
3 A medical device with high risk that requires premarket approval 2