MANZA HA NON-CEMENTED CUP - MANZA HA NON-CEMENTED CUP MULTI HOLE, 56MM - STINSON ORTHOPEDICS INC.

Duns Number:080460688

Device Description: MANZA HA NON-CEMENTED CUP MULTI HOLE, 56MM

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More Product Details

Catalog Number

101-20-056

Brand Name

MANZA HA NON-CEMENTED CUP

Version/Model Number

101-20-056

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

K153131

Product Code Details

Product Code

KWZ

Product Code Name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Device Record Status

Public Device Record Key

7202c4e3-5a91-4d55-b78f-a145d1a4a723

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

December 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STINSON ORTHOPEDICS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 255