Catalog Number

7207035D

Brand Name

ACUFEX

Version/Model Number

7207035D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2021

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

K961853

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

bd2e1467-b1a5-41e1-8a2f-428936b6eb8f

Public Version Date

July 01, 2021

Public Version Number

4

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-