Trevo XP - Trevo XP Provue Retriever - Stryker Corporation

Duns Number:042405446

Device Description: Trevo XP Provue Retriever

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More Product Details

Catalog Number

90186

Brand Name

Trevo XP

Version/Model Number

90186

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

K143077

Product Code Details

Product Code

NRY

Product Code Name

CATHETER, THROMBUS RETRIEVER

Device Record Status

Public Device Record Key

9019e540-b205-4754-9af9-c59da5ade563

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2688
2 A medical device with a moderate to high risk that requires special controls. 5304
3 A medical device with high risk that requires premarket approval 86