SUBTALAR SPACER SYSTEM - WRIGHT MEDICAL TECHNOLOGY, INC.

Duns Number:807201207

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More Product Details

Catalog Number

02-005

Brand Name

SUBTALAR SPACER SYSTEM

Version/Model Number

02-005

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

HXB

Product Code Name

PROBE

Device Record Status

Public Device Record Key

8d46aba1-f26e-4db7-98e8-3e453c233fc2

Public Version Date

August 11, 2022

Public Version Number

4

DI Record Publish Date

January 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WRIGHT MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1994
2 A medical device with a moderate to high risk that requires special controls. 5554