SCP 3.2mm Blade Pin - ZIMMER KNEE CREATIONS, INC.

Duns Number:078836317

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More Product Details

Catalog Number

303.232

Brand Name

SCP 3.2mm Blade Pin

Version/Model Number

303.232

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

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

HXK

Product Code Name

Holder, Needle; Orthopedic

Device Record Status

Public Device Record Key

e120e056-4249-46d3-8ff8-1d7ef884d5ff

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER KNEE CREATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 8