OSSIOfiber® Compression Staple System OF2061515S
GUDID 07290017630694
OSSIOfiber® Compression Staple System, 15 x 15 mm. Package contains: 1 Implant, and 1 Instrument pack.
OSSIO LTD
Orthopaedic bone staple, non-adjustable| Primary Device ID | 07290017630694 |
| NIH Device Record Key | 4b18184b-ae68-48c9-b9a8-72e609eebdc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSIOfiber® Compression Staple System |
| Version Model Number | OF2061515S |
| Catalog Number | OF2061515S |
| 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
Device Dimensions
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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 |
| 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 |
| 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 |
| 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 | 07290017630694 [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 | 2023-03-23 |
| Device Publish Date | 2023-03-15 |
On-Brand Devices [OSSIOfiber® Compression Staple System]
| 07290017630694 | OSSIOfiber® Compression Staple System, 15 x 15 mm. Package contains: 1 Implant, and 1 Instrum |
| 07290017630700 | OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrum |
| 07290017630670 | OSSIOfiber® Compression Staple System, 9 x 10 mm. Package contains: 1 Implant, and 1 Instrume |
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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