Catalog Number

S-915

Brand Name

DEKNATEL

Version/Model Number

IPN025490

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

GAP

Product Code Name

SUTURE, NONABSORBABLE, SILK

Public Device Record Key

95873a23-7a0f-42f3-875b-6065af98c5fd

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

March 24, 2017

Package DI Number

14026704592682

Quantity per Package

36

Contains DI Package

34026704592686

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box