AccessGUDID - DEVICE: OSSIOfiber® Trimmable Fixation Nail System, Cannulated (07290017630250)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Trimmable Fixation Nail System, Cannulated
Version or Model: OF2054070S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF2054070S
Company Name: OSSIO LTD

Primary DI Number: 07290017630250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600505107 *Terms of Use

Device Description: OSSIOfiber® Trimmable Fixation Nail System, 4.0x70mm, Cannulated. 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?
45037	Orthopaedic bone pin, bioabsorbable	A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.	Active	true
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

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
Length: 70 Millimeter
Outer Diameter: 4.0 Millimeter

Device Record Status

Public Device Record Key: 8d6f45b3-0b7b-4143-aeb0-698106fa1aad
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: January 02, 2022