AccessGUDID - DEVICE: OSSIOfiber® Hammertoe Fixation System (07290017630106)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Hammertoe Fixation System
Version or Model: OF20029191
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF20029191
Company Name: OSSIO LTD

Primary DI Number: 07290017630106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600505107 *Terms of Use

Device Description: The OSSIOfiber® Hammertoe Fixation System, M, 2.9X19 mm, angled 10°. Package contains: 1 K-wire, 1 Drill Bit, 1 Inserter, 1 Implant angled 10°.

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 [?]
K190652	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
Special Storage Condition, Specify: Do not expose product to temperatures greater than 47°C or 116°F.
Special Storage Condition, Specify: Store at a normal relative humidity
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 7 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.9 Millimeter
Length: 19 Millimeter

Device Record Status

Public Device Record Key: 37635d2e-1494-4a6b-8601-ef7ec1f14f0f
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: March 12, 2020