AccessGUDID - DEVICE: OSSIOfiber® Compression Staple (07290017630885)

GUDID

Device Identifier (DI) Information

Brand Name: OSSIOfiber® Compression Staple
Version or Model: OF1061515S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OF1061515S
Company Name: OSSIO LTD

Primary DI Number: 07290017630885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600505107 *Terms of Use

Device Description: OSSIOfiber® Compression Staple, 15X15 mm. 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?
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNU	Staple, Absorbable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212594	000
K241932	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
Device Size Text, specify: 15 X 15 mm

Device Record Status

Public Device Record Key: 797b83fe-3604-46c7-86be-6390f9bc3d11
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: March 15, 2023