OsteoGen Strip

GUDID 00855286006129

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

Impladent, Ltd.

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