AccessGUDID - DEVICE: OSSIOfiber® Trimmable Fixation Nail, Cannulated (07290019361060)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Trimmable Fixation Nail, Cannulated
Version or Model: OF1054100S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF1054100S
Company Name: OSSIO LTD

Primary DI Number: 07290019361060
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, 4.0x100mm, Cannulated. Package contains: 1 Implant.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
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

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230750	000
K231272	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: 4.0 Millimeter
Length: 100 Millimeter

Device Record Status

Public Device Record Key: 7d5dbf38-caf5-4d38-a8e6-96c7e6622a30
Public Version Date: February 02, 2024
Public Version Number: 1
DI Record Publish Date: January 25, 2024