SALVATION - System Tray 4 - WRIGHT MEDICAL TECHNOLOGY, INC.

Duns Number:807201207

Device Description: System Tray 4

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More Product Details

Catalog Number

SEF94012

Brand Name

SALVATION

Version/Model Number

SEF94012

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

a0632508-2eba-4c48-b68d-b5061fd3b113

Public Version Date

September 16, 2022

Public Version Number

9

DI Record Publish Date

September 17, 2016

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