Catalog Number

S161

Brand Name

Single Use Surgical Professional

Version/Model Number

S161

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

-

Product Code

HTX

Product Code Name

Rongeur

Public Device Record Key

3671cfd2-6540-4746-a949-2ae65e357e00

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 19, 2016

Package DI Number

05055299102541

Quantity per Package

6

Contains DI Package

05055299102534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton