Catalog Number

FG-0017

Brand Name

TenSURE

Version/Model Number

80-02

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

FZT

Product Code Name

Cutter, Surgical

Public Device Record Key

0108dfb7-b808-40c6-9618-1a64620610c3

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

30840143901915

Quantity per Package

1

Contains DI Package

10840143901911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box