AccessGUDID - DEVICE: PEEK Zip (07613252232490)

GUDID

Device Identifier (DI) Information

Brand Name: PEEK Zip
Version or Model: 3910-200-036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3910-200-036
Company Name: STRYKER CORPORATION

Primary DI Number: 07613252232490
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: 5.5MM PEEK ZIP SUTURE ANCHOR

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
Tendon bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of soft tissues/tendons 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

Tendon bone anchor, non-bioabsorbable

A non-bioabsorbable device designed to be implanted into bone for the attachment of soft tissues/tendons 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
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070758	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

[?]

Size Type Text
Device Size Text, specify: Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: bb08cd88-c558-471d-8d90-b7d76d392b53
Public Version Date: January 08, 2019
Public Version Number: 4
DI Record Publish Date: September 04, 2015