A-graft®[Bone grafting material,Animal source]

GUDID 00814913025025

HIOSSEN, INC.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00814913025025
• NIH Device Record Key: a303fce0-c0c8-4c99-860e-7fb2e1d7fc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A-graft®[Bone grafting material,Animal source]
• Version Model Number: HAS010LV
• Company DUNS: 796083090
• Company Name: HIOSSEN, INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814913025025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151542

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-03
• Device Publish Date: 2018-04-27

On-Brand Devices [A-graft®[Bone grafting material,Animal source]]

• 00814913025063: HAS200LV
• 00814913025056: HAS100LV
• 00814913025049: HAS050LV
• 00814913025032: HAS025LV
• 00814913025025: HAS010LV
• 00814913025001: HAS100SV
• 00814913024998: HAS050SV
• 00814913024981: HAS025SV
• 00814913024974: HAS010SV