AccessGUDID - DEVICE: OSSIOfiber® Suture Anchor System (07290017630656)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Suture Anchor System
Version or Model: OF2034750S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF2034750S
Company Name: OSSIO LTD

Primary DI Number: 07290017630656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600505107 *Terms of Use

Device Description: OSSIOfiber® Suture Anchor System - Two 4.75 mm with Suture Snare. Package contains: 2 OSSIOfiber Suture Anchor with Snare, 4.75 mm, 1 OSSIO Punch, 1 Solid Black 2mm Tape Suture, 1 Blue/Black 2mm Tape Suture.

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?
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.	Active	false
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
OJH	Orthopedic Tray

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
Special Storage Condition, Specify: Do not expose product to temperatures greater than 47°C or 116°F
Storage Environment Temperature: between 7 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Store at a normal relative humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.75 Millimeter

Device Record Status

Public Device Record Key: 9a40d2ca-0e4e-4a15-9579-03d3e2a392f7
Public Version Date: June 14, 2022
Public Version Number: 1
DI Record Publish Date: June 06, 2022