Catalog Number

-

Brand Name

Cytoplast™ PTFE Suture

Version/Model Number

CS0528BK

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

7927d875-18ad-4c19-bcaa-3c6bc7516ba7

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

February 22, 2019

Package DI Number

D765CS0528BK1

Quantity per Package

12

Contains DI Package

D765CS0528BK0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box