AccessGUDID - DEVICE: OSSIOfiber® Threaded Trimmable Fixation Nail System (07290019361084)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Threaded Trimmable Fixation Nail System
Version or Model: OF2084510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF2084510S
Company Name: OSSIO LTD

Primary DI Number: 07290019361084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600505107 *Terms of Use

Device Description: OSSIOfiber® Threaded Trimmable Fixation Nail System, H/W 4.5x70mm. 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
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	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: 4.5 Millimeter
Length: 70 Millimeter

Device Record Status

Public Device Record Key: 6557c3ad-be3b-4428-bf4c-0c7d18fda6c6
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: August 18, 2024