INSTRUMENT - EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL

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More Product Details

Catalog Number

0937-3-215

Brand Name

INSTRUMENT

Version/Model Number

0937-3-215

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

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

9a96916f-8ee1-4cfa-ab62-3cf50730bd0d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

07613327141351

Quantity per Package

5

Contains DI Package

17613327141358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"HOWMEDICA OSTEONICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5091
2 A medical device with a moderate to high risk that requires special controls. 10216
3 A medical device with high risk that requires premarket approval 32