INSTRUMENT - Specialty Spacer Shim 13 MM - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: Specialty Spacer Shim 13 MM

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More Product Details

Catalog Number

I-K4204SS13

Brand Name

INSTRUMENT

Version/Model Number

I-K4204SS13

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

-

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

ce88170a-170c-4a7c-82e8-d6edbb0193f5

Public Version Date

May 13, 2019

Public Version Number

1

DI Record Publish Date

May 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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