Catalog Number

400-3031

Brand Name

PONTiS Flexor Tendon Repair System

Version/Model Number

400-3031

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K101126,K133579

Product Code

GAQ

Product Code Name

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Public Device Record Key

8e342132-b741-4037-aad3-af0e366c7ece

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-