Catalog Number

013636

Brand Name

NA

Version/Model Number

013636

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

-

Product Code

KGS

Product Code Name

RETENTION DEVICE, SUTURE

Public Device Record Key

12b71a9b-57bb-4353-8a0b-2a4f2c7b1f54

Public Version Date

January 31, 2020

Public Version Number

5

DI Record Publish Date

August 30, 2015

Package DI Number

23596010025146

Quantity per Package

6

Contains DI Package

03596010025142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX