Catalog Number

9141355H

Brand Name

EBERLE

Version/Model Number

9141355H

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

K092977,K092977

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

dc8c7857-8c92-4fb0-b4cd-bf55b814eeb2

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

04050052030926

Quantity per Package

5

Contains DI Package

04050052025601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-