OsteoGen Strip

GUDID 00855286006129

OsteoGen Strips. OsteoGen bone graft combined with a bovine achilles tendon carrier

Impladent, Ltd.

Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft

• Primary Device ID: 00855286006129
• NIH Device Record Key: 73bdca7f-526c-40ce-be4e-1ca137da16b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoGen Strip
• Version Model Number: OSL20403
• Company DUNS: 199838400
• Company Name: Impladent, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855286006112 [Primary]
GS1	00855286006129 [Package]; Contains: 00855286006112; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090794

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

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: 2023-08-30
• Device Publish Date: 2023-08-22

Devices Manufactured by Impladent, Ltd.

• 00855286006129 - OsteoGen Strip: 2023-08-30OsteoGen Strips. OsteoGen bone graft combined with a bovine achilles tendon carrier
• 00855286006129 - OsteoGen Strip: 2023-08-30 OsteoGen Strips. OsteoGen bone graft combined with a bovine achilles tendon carrier
• 00855286006266 - OsteoGen Strip - Small: 2023-08-30 OsteoGen Strips. OsteoGen bone graft combined with a bovine achilles tendon carrier
• 00855286006341 - OsteoGen Block: 2023-08-30 OsteoGen Block. OsteoGen bone graft combined with a bovine achilles tendon carrier
• 00855286006433 - OsteoGen Plugs - Extra Large: 2023-08-30 OsteoGen Plugs. OsteoGen bone graft combined with a bovine achilles tendon carrier
• 00855286006136 - TriStar Screws - 3mm (Pack of 5): 2018-07-06 Pack of 5 Ti-Alloy Screws, Length: 3mm, fully threaded
• 00855286006143 - TriStar Screws - 4mm (Pack of 5): 2018-07-06 Pack of 5 Ti-Alloy Screws, Length: 4mm, fully threaded
• 00855286006150 - TriStar Screws - 5mm (Pack of 5): 2018-07-06 Pack of 5 Ti-Alloy Screws, Length: 5mm, fully threaded
• 00855286006167 - TriStar Screws - 6mm (Pack of 5): 2018-07-06 Pack of 5 Ti-Alloy Screws, Length: 6mm total, 4mm threaded, 2mm unthreaded