Mainstay - 3.5MM MAINSTAY ZIP ANCHOR WITH ? CIRCLE CUTTING - STRYKER CORPORATION

Duns Number:187502109

Device Description: 3.5MM MAINSTAY ZIP ANCHOR WITH ? CIRCLE CUTTING NEEDLE, 2 STRANDS #0 BRAIDED POLYESTER

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More Product Details

Catalog Number

3910-002-235

Brand Name

Mainstay

Version/Model Number

3910-002-235

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2017

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

K965175

Product Code Details

Product Code

JDR

Product Code Name

STAPLE, FIXATION, BONE

Device Record Status

Public Device Record Key

a2ad4a42-cf9e-4799-ade3-caddb53fbf9d

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 09, 2015

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 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60