Catalog Number

-

Brand Name

Polypropylene Sutures

Version/Model Number

9117

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080684,K080684,K080684

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

826fe374-6076-473f-8699-b5b8b6302fd9

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00616784911731

Quantity per Package

25

Contains DI Package

00616784911724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-