Catalog Number

DERMA-TS3103

Brand Name

Suture Strip®

Version/Model Number

TS-3103

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

Product Code

FPX

Product Code Name

Strip, adhesive, closure, skin

Public Device Record Key

d901409f-f074-48b9-a69a-20a11b84115c

Public Version Date

March 22, 2019

Public Version Number

1

DI Record Publish Date

March 14, 2019

Package DI Number

30753567331032

Quantity per Package

4

Contains DI Package

10753567331038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case