Catalog Number

-

Brand Name

POLYBOND®

Version/Model Number

CP665A

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

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

44ef4e58-d68b-433d-86c3-8031eeccfe1e

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

April 13, 2017

Package DI Number

20790986006779

Quantity per Package

12

Contains DI Package

10790986006918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-