OSSIOfiber® Suture Anchor OF1034752S

GUDID 07290017630618

OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 1.8mm Suture Tape, 1 Blue/White Round #2 Suture, 4 Stainless Steel MO-6 Needles.

OSSIO LTD

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 07290017630618
• NIH Device Record Key: 56dcdddb-9ee0-4ac5-b9e6-ea9ca93013e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIOfiber® Suture Anchor
• Version Model Number: OF1034752S
• Catalog Number: OF1034752S
• 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: 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

Device Dimensions

• Outer Diameter: 4.75 Millimeter
• Outer Diameter: 4.75 Millimeter
• Outer Diameter: 4.75 Millimeter
• Outer Diameter: 4.75 Millimeter
• Outer Diameter: 4.75 Millimeter
• Outer Diameter: 4.75 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017630618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213415

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [OSSIOfiber® Suture Anchor]

• 07290017630649: OSSIOfiber® Suture Anchor 4.75 mm Blue/Black Tape, Blue #2 Suture. Package contains: 1 Implant,
• 07290017630632: OSSIOfiber® Suture Anchor 4.75 mm with Black Tape, Blue/White #2 Suture. Package contains: 1 Im
• 07290017630625: OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black/White Tape, Blue #2 Suture. Package conta
• 07290017630618: OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Package con
• 07290017630601: OSSIOfiber® Suture Anchor 4.75 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1
• 07290017630946: OSSIOfiber® Suture Anchor 5.5 mm with Suture Snare. Package contains: 1 Implant,1 Inserter,1 S