Catalog Number

ST650

Brand Name

CP FIBER

Version/Model Number

ST650

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

K041894,K094028,K041894,K094028,K041894,K094028

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

4827d2f7-f224-4cf7-aab6-56b78d50db8a

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

December 21, 2015

Package DI Number

20790986004676

Quantity per Package

12

Contains DI Package

10790986004679

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-