Partial Pelvis Replacement - 5 hole flanges - WALDEMAR LINK GmbH & Co. KG

Duns Number:315675488

Device Description: 5 hole flanges

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More Product Details

Catalog Number

15-8205/67

Brand Name

Partial Pelvis Replacement

Version/Model Number

15-8205/67

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

K943986

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

9dc39aa6-55e6-4603-9bce-9af70603b074

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2015

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