OSSIOfiber® Trimmable Fixation Nail, Cannulated OF1054100S

GUDID 07290019361060

OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant.

OSSIO LTD

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• Primary Device ID: 07290019361060
• NIH Device Record Key: 7d5dbf38-caf5-4d38-a8e6-96c7e6622a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIOfiber® Trimmable Fixation Nail, Cannulated
• Version Model Number: OF1054100S
• Catalog Number: OF1054100S
• Company DUNS: 600505107
• Company Name: OSSIO LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io
• Phone: 1-833-781-7373
• Email: customer_service@ossio.io

Device Dimensions

• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 100 Millimeter

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019361060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230750

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2024-02-02
• Device Publish Date: 2024-01-25

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