AccessGUDID - DEVICE: Mainstay (04546540792501)

GUDID

Device Identifier (DI) Information

Brand Name: Mainstay
Version or Model: 3910-002-035
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3910-002-035
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540792501
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Soft-tissue anchor, non-bioabsorbable	A device designed to be implanted into bone for the attachment of soft tissues either directly or via a suture attached to the device; it is not dedicated to ligament anchoring. It is typically used in shoulder and some lower-limb operations, and functions as an alternative to drilling a hole in bone for passing a suture. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

GMDN Preferred Term Name

GMDN Definition

Soft-tissue anchor, non-bioabsorbable

A device designed to be implanted into bone for the attachment of soft tissues either directly or via a suture attached to the device; it is not dedicated to ligament anchoring. It is typically used in shoulder and some lower-limb operations, and functions as an alternative to drilling a hole in bone for passing a suture. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

FDA Product Code

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Product Code	Product Code Name
JDR	STAPLE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K965175	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter: 3.5 Millimeter

Device Record Status

Public Device Record Key: 889ac8ce-346d-441c-9572-9614c1bd437e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2015