AccessGUDID - DEVICE: OSSIOfiber™ Hammertoe Fixation Implant (07290017630007)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber™ Hammertoe Fixation Implant
Version or Model: 2.9X19 mm straight
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF10129190
Company Name: OSSIO LTD

Primary DI Number: 07290017630007
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 Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

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 [?]
K181180	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
Length: 19 Millimeter
Outer Diameter: 2.9 Millimeter

Device Record Status

Public Device Record Key: 78d7e0f8-765f-42dc-be01-d21b0d98c6b5
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: April 15, 2019