X-FUSE - Trial for implant XS - Stryker Trauma SA

Duns Number:481999654

Device Description: Trial for implant XS

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More Product Details

Catalog Number

XFA006000

Brand Name

X-FUSE

Version/Model Number

XFA006000

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

1f5b0d1f-f35e-47e4-8155-5927f5b64013

Public Version Date

June 06, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER TRAUMA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2606
2 A medical device with a moderate to high risk that requires special controls. 9953
3 A medical device with high risk that requires premarket approval 186