Stratum RS - Stratum Reduced Size T Plate - 8 Hole - Nextremity Solutions, Inc.

Duns Number:060783407

Device Description: Stratum Reduced Size T Plate - 8 Hole

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More Product Details

Catalog Number

-

Brand Name

Stratum RS

Version/Model Number

STRM-T8-RS

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

K200785

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

1926833f-6630-40f4-b652-7a640c2c37fc

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

November 10, 2020

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