Osseo Seal

GUDID D914OSS100010

Osseo Seal 1.0 cc Bovine bone graft 250-1000 micron vial

ODONTIT S.A.

Dental bone matrix implant, animal-derived

• Primary Device ID: D914OSS100010
• NIH Device Record Key: d7c7bf6d-273c-48da-bbda-d6f2e5d8c609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osseo Seal
• Version Model Number: OSS-1000-10
• Company DUNS: 972044937
• Company Name: ODONTIT S.A.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D914OSS100010 [Primary]

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: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [Osseo Seal]

• D914OSS100040: Osseo Seal 4.0 cc Bovine bone graft 250-1000 micron vial
• D914OSS100010: Osseo Seal 1.0 cc Bovine bone graft 250-1000 micron vial
• D914OSS100005: Osseo Seal 0.5 cc Bovine bone graft 250-1000 micron vial