OSSIOfiber® Threaded Trimmable Fixation Nail System OF2095520S
GUDID 07290019361114
OSSIOfiber® Threaded Trimmable Fixation Nail System, F/A 5.5x70mm. Package contains: 1 Implant, and 1 Instrument pack.
OSSIO LTD
Orthopaedic surgical procedure kit, non-medicated, single-use| Primary Device ID | 07290019361114 |
| NIH Device Record Key | 1c11a399-9db6-4696-b8a0-8e8eca43f366 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIOfiber® Threaded Trimmable Fixation Nail System |
| Version Model Number | OF2095520S |
| Catalog Number | OF2095520S |
| Company DUNS | 600505107 |
| Company Name | OSSIO LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io | |
| Phone | 1-833-781-7373 |
| customer_service@ossio.io |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 70 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose product to temperatures greater than 47°C or 116°F |
| Storage Environment Temperature | Between 7 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Store at a normal relative humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290019361114 [Primary] |
FDA Product Code
| OJH | Orthopedic Tray |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-02 |
| Device Publish Date | 2024-11-24 |
On-Brand Devices [OSSIOfiber® Threaded Trimmable Fixation Nail System]
| 07290019361091 | OSSIOfiber® Threaded Trimmable Fixation Nail System, F/A 4.5x70mm. Package contains: 1 Implant |
| 07290019361084 | OSSIOfiber® Threaded Trimmable Fixation Nail System, H/W 4.5x70mm. Package contains: 1 Implant |
| 07290019361114 | OSSIOfiber® Threaded Trimmable Fixation Nail System, F/A 5.5x70mm. Package contains: 1 Implant |
Trademark Results [OSSIOfiber]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIOFIBER 79255262 not registered Live/Pending |
OSSIO LTD 2018-11-29 |
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