Zimmertrodes - Zimmer MedizinSysteme GmbH

Duns Number:316111251

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More Product Details

Catalog Number

87200171

Brand Name

Zimmertrodes

Version/Model Number

87200171

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

K140340,K140340,K140340,K140340

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

ab481b4a-2f03-4a80-98f4-e313a0dc4b65

Public Version Date

March 18, 2021

Public Version Number

1

DI Record Publish Date

March 10, 2021

Additional Identifiers

Package DI Number

24053815072915

Quantity per Package

8

Contains DI Package

14053815072918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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