EBERLE - Reamer, AO Synthes / ASIF / PROTEK - Eberle GmbH & Co. KG

Duns Number:315919220

Device Description: Reamer, AO Synthes / ASIF / PROTEK

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More Product Details

Catalog Number

913023

Brand Name

EBERLE

Version/Model Number

913023

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

-

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 Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

386b5f83-bac7-4de7-94cd-5b5440196b8e

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

June 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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