N/A - Awl Cone Prosthesis ø 22 - Zimmer GmbH

Duns Number:488133448

Device Description: Awl Cone Prosthesis ø 22

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

75.11.15-220

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113556

Product Code Details

Product Code

JDI

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Device Record Status

Public Device Record Key

4e53cd00-e45d-488f-b420-4687612f7f91

Public Version Date

October 14, 2019

Public Version Number

3

DI Record Publish Date

November 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 338
2 A medical device with a moderate to high risk that requires special controls. 3101