Stimulation Electrode Cable (Yellow) - Otto Bock Healthcare Products GmbH

Duns Number:300802068

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More Product Details

Catalog Number

-

Brand Name

Stimulation Electrode Cable (Yellow)

Version/Model Number

9001C02=4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 2020

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

K080950

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

d44e7ecd-9c48-4b6e-b3ee-53d12e57988a

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OTTO BOCK HEALTHCARE PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 86