AccessGUDID - DEVICE: OSSIOfiber® Suture Anchor (07290019361169)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Suture Anchor
Version or Model: OF1032553S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF1032553S
Company Name: OSSIO LTD

Primary DI Number: 07290019361169
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 2.5 mm, with 1.4 mm White/Blue Suture Tape with Needles. Package contains: 1 Implant, 1 Inserter, 1 White/Blue 1.4 mm Suture Tape, 2 Stainless Steel MO-6 Needles.

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

[?]

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 [?]
K243760	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
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
Special Storage Condition, Specify: Do not expose product to temperatures greater than 47°C or 116°F

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.5 Millimeter

Device Record Status

Public Device Record Key: 2935242d-ec31-400d-af79-526b290986ae
Public Version Date: June 06, 2025
Public Version Number: 1
DI Record Publish Date: May 29, 2025