Stratum - STRM 1st MPJ Plate Std 0° Rt - Nextremity Solutions, Inc.

Duns Number:060783407

Device Description: STRM 1st MPJ Plate Std 0° Rt

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More Product Details

Catalog Number

-

Brand Name

Stratum

Version/Model Number

STRM-1MPJ-STDR

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

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

9c8442d8-08ba-475a-bc84-a78b74116cf8

Public Version Date

September 23, 2022

Public Version Number

3

DI Record Publish Date

December 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXTREMITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 152
2 A medical device with a moderate to high risk that requires special controls. 560