Zimmertrodes - Medium - Zimmer MedizinSysteme GmbH

Duns Number:316111251

Device Description: Medium

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More Product Details

Catalog Number

87200141

Brand Name

Zimmertrodes

Version/Model Number

87200141

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"

Yes

For Single-Use

Yes

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

-

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

9823deb3-7ffa-44ae-817d-a0de2edc6d52

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

34053815054420

Quantity per Package

5

Contains DI Package

24053815054423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ZIMMER MEDIZINSYSTEME GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 19