AccessGUDID - DEVICE: OSSIOfiber® Compression Staple System (07290017630700)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Compression Staple System
Version or Model: OF2062020S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF2062020S
Company Name: OSSIO LTD

Primary DI Number: 07290017630700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600505107 *Terms of Use

Device Description: OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrument pack.

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
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	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
Device Size Text, specify: 20 x 20 mm

Device Record Status

Public Device Record Key: 648a2032-b4de-4477-bd2e-5b6549feb917
Public Version Date: May 16, 2024
Public Version Number: 2
DI Record Publish Date: December 25, 2022