Catalog Number

DERMA-TS3101B

Brand Name

Suture Strip®

Version/Model Number

TS-3101B

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"

Yes

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

K894205,K894205,K894205

Product Code

FPX

Product Code Name

Strip, adhesive, closure, skin

Public Device Record Key

ac683c49-2fbc-452a-9e6f-bc524d1557df

Public Version Date

November 23, 2018

Public Version Number

1

DI Record Publish Date

October 23, 2018

Package DI Number

00809958000106

Quantity per Package

10

Contains DI Package

00809958000083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case