TwinLoop - 3.5MM TWINLOOP PEEK WITH SUTURE EYELET, 1 STRAND - STRYKER CORPORATION

Duns Number:187502109

Device Description: 3.5MM TWINLOOP PEEK WITH SUTURE EYELET, 1 STRAND #2 FORCE FIBER

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More Product Details

Catalog Number

3910-400-135

Brand Name

TwinLoop

Version/Model Number

3910-400-135

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

-

Product Code Details

Product Code

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Device Record Status

Public Device Record Key

efa1af38-8de5-45e4-90b5-61e007aef8d9

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

August 26, 2015

Additional Identifiers

Package DI Number

34546540678301

Quantity per Package

5

Contains DI Package

04546540678300

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