Catalog Number

-

Brand Name

Cytoplast™ PTFE Suture

Version/Model Number

CS0618PREM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

962087f3-d836-4d8e-b979-fe9ef62c1198

Public Version Date

February 05, 2021

Public Version Number

7

DI Record Publish Date

April 29, 2016

Package DI Number

D765CS0618PREM1

Quantity per Package

12

Contains DI Package

D765CS0618PREM0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box