LEVEL ONE CMF - SCREW, MAXDRIVE, MMF, DRILL FREE, WIDE THD, 46* - KLS-Martin L.P.

Duns Number:826499238

Device Description: SCREW, MAXDRIVE, MMF, DRILL FREE, WIDE THD, 46* FLUTE, STAINLESS STEEL ASTM F138

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More Product Details

Catalog Number

-

Brand Name

LEVEL ONE CMF

Version/Model Number

99-580-28-53

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2021

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

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Device Record Status

Public Device Record Key

9fafae79-19fc-49c3-b8b5-e38bddf03f74

Public Version Date

April 21, 2021

Public Version Number

8

DI Record Publish Date

October 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KLS-MARTIN L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7013
2 A medical device with a moderate to high risk that requires special controls. 4618