Catalog Number

-

Brand Name

Biotex

Version/Model Number

BT4019

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

K180992

Product Code

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

cb31f9a7-58d8-4b4f-96c0-ee02214eb3b9

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-