LINK Embrace Shoulder System - Humeral Head - WALDEMAR LINK GmbH & Co. KG

Duns Number:315675488

Device Description: Humeral Head

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More Product Details

Catalog Number

642-044/16

Brand Name

LINK Embrace Shoulder System

Version/Model Number

642-044/16

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

K210899

Product Code Details

Product Code

HSD

Product Code Name

PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Record Status

Public Device Record Key

6145f61e-01cf-4d95-8118-60ccdc32321d

Public Version Date

October 15, 2021

Public Version Number

1

DI Record Publish Date

October 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WALDEMAR LINK GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 154
2 A medical device with a moderate to high risk that requires special controls. 3922
U Unclassified 42