OsteoMed - 2.0mm Right L Plate, 23mm, Rigid - OSTEOMED LLC

Duns Number:606417780

Device Description: 2.0mm Right L Plate, 23mm, Rigid

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More Product Details

Catalog Number

210-0254

Brand Name

OsteoMed

Version/Model Number

210-0254

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

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Device Record Status

Public Device Record Key

0d34d8a9-b776-4bb4-a7b0-095b583a12e8

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

April 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSTEOMED LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 95
2 A medical device with a moderate to high risk that requires special controls. 7762
U Unclassified 105