Catalog Number

OF141631

Brand Name

Onatec

Version/Model Number

OF141631

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

c6df72a9-22f9-45f7-b6a1-1d68a7a4c511

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Package DI Number

10848782029881

Quantity per Package

12

Contains DI Package

00848782029884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box