Catalog Number

2S-1-50W

Brand Name

SUPRAMID

Version/Model Number

2S-1-50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2016

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

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

185cfefe-fde5-425a-b5ef-e2a082197669

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 13, 2016

Package DI Number

20816848021677

Quantity per Package

12

Contains DI Package

10816848020229

Package Discontinue Date

December 31, 2016

Package Status

Not in Commercial Distribution

Package Type

Box