Catalog Number

385S

Brand Name

N/A

Version/Model Number

385S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAP

Product Code Name

Suture, Nonabsorbable, Silk

Public Device Record Key

0c1644fe-248b-4ad8-82a2-b7783ba9cd77

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

December 21, 2015

Package DI Number

20790986002894

Quantity per Package

12

Contains DI Package

10790986002897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-