Osseointegration Prosthetic Limb OPL-LLC-OR

GUDID 19356371001091

Spare O-Rings

OSSEOINTEGRATION INTERNATIONAL PTY LTD

External lower-limb prosthesis structural/alignment component

• Primary Device ID: 19356371001091
• NIH Device Record Key: 15b20da4-907e-4364-99e4-5cae48b753a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osseointegration Prosthetic Limb
• Version Model Number: O-Ring
• Catalog Number: OPL-LLC-OR
• Company DUNS: 743779676
• Company Name: OSSEOINTEGRATION INTERNATIONAL PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19356371001091 [Primary]

FDA Product Code

• IQO: Device, Prosthesis Alignment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [Osseointegration Prosthetic Limb]

• 19356371001121: 8 mm Hex Clamp Screw
• 19356371001114: 5 mm Hex Distal Locking Screw - M14 Includes O-Ring
• 19356371001107: 5 mm Hex Distal Locking Screw - M10 Includes O-ring
• 19356371001091: Spare O-Rings