Eberle Shaver Blades - Round Burr 3,5 - Eberle GmbH & Co. KG

Duns Number:315919220

Device Description: Round Burr 3,5

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More Product Details

Catalog Number

9141035

Brand Name

Eberle Shaver Blades

Version/Model Number

9141035

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

d4451a68-1857-462e-a523-8fd6aee46876

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

April 05, 2018

Additional Identifiers

Package DI Number

04050052029517

Quantity per Package

5

Contains DI Package

04050052015800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"EBERLE GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 106