FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSIOfiber® Compression Staple System
DI: 07290017630694
·
Model: OF2061515S
·
OSSIO LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSSIOfiber® Compression Staple System
- Primary DI
- 07290017630694
- Version / Model
- OF2061515S
- Catalog Number
- OF2061515S
- Company Name
- OSSIO LTD
- Labeler DUNS
- 600505107
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-15
- Public Version
- 1
- Public Version Date
- 2023-03-23
- Public Version Status
- New
- Public Device Record Key
- 4b18184b-ae68-48c9-b9a8-72e609eebdc4
Device Description
OSSIOfiber® Compression Staple System, 15 x 15 mm. Package contains: 1 Implant, and 1 Instrument pack.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJH | Orthopedic Tray | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017630694 | GS1 |
Customer Contacts
- Phone
- 1-833-781-7373
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 x 15 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose product to temperatures greater than 47°C or 116°F
- Type
- Storage Environment Temperature
- Temperature Range
- 7 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at a normal relative humidity