AccessGUDID - DEVICE: Mainstay (04546540792501)

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Device Identifier (DI) Information

Brand Name: Mainstay
Version or Model: 3910-002-035
Catalog Number: 3910-002-035
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540792501
Issuing Agency: GS1
Device Count: 1

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

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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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 Status

Commercial Distribution Status: Not in Commercial Distribution
DI Record Publish Date: September 09, 2015
Commercial Distribution End Date: December 07, 2016