NA - COCR HUMERAL STEM CEMENTED SIZE 8/200MM - SYNTHES (U.S.A.) LP

Duns Number:832637081

Device Description: COCR HUMERAL STEM CEMENTED SIZE 8/200MM XLONG-STERILE

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More Product Details

Catalog Number

5624820XL

Brand Name

NA

Version/Model Number

5624-8/20XL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 28, 2020

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

K072578

Product Code Details

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Record Status

Public Device Record Key

ac642624-02a2-41df-b3c8-67c9e1130af5

Public Version Date

June 29, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES (U.S.A.) LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1194
2 A medical device with a moderate to high risk that requires special controls. 4171
3 A medical device with high risk that requires premarket approval 30
U Unclassified 1