AccessGUDID - DEVICE: ZipE® Knotless Tissue Repair and Attachment Devices (10858816006016)

GUDID

Device Identifier (DI) Information

Brand Name: ZipE® Knotless Tissue Repair and Attachment Devices
Version or Model: RA6-6565-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIPTEK LLC

Primary DI Number: 10858816006016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 035237962 *Terms of Use

Device Description: ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAI	Fastener, Fixation, Biodegradable, Soft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 54cf5b13-414e-40b8-834c-c28595eed2a8
Public Version Date: June 12, 2019
Public Version Number: 1
DI Record Publish Date: June 04, 2019