Catalog Number

X0262048

Brand Name

Silkam

Version/Model Number

X0262048

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

ec6bd737-9246-4213-8060-a1557e1496a1

Public Version Date

April 12, 2021

Public Version Number

7

DI Record Publish Date

August 27, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-