XBraid - 2.0MM XBRAID TT, 100% UHMWPE, VIOLET - STRYKER CORPORATION

Duns Number:187502109

Device Description: 2.0MM XBRAID TT, 100% UHMWPE, VIOLET

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More Product Details

Catalog Number

3910-900-019

Brand Name

XBraid

Version/Model Number

3910-900-019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Device Record Status

Public Device Record Key

530d44d5-48c7-4ebe-9454-50bd4963a848

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

November 19, 2015

Additional Identifiers

Package DI Number

37613327261494

Quantity per Package

12

Contains DI Package

07613327261493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60