Catalog Number

-

Brand Name

Anchor Curved Tip Kerrison Rongeur

Version/Model Number

PSZ-400-201

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

-

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

K161878

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

530565a8-ce17-413a-93da-d37f8a7766bb

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

June 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-