A-Oss®

GUDID 00814913024233

HIOSSEN, INC.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00814913024233
• NIH Device Record Key: ba23c038-660a-45bf-b0e5-f45e7c5d1243
• Commercial Distribution Discontinuation: 2018-04-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: A-Oss®
• Version Model Number: AOSN050SV
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814913024233 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

On-Brand Devices [A-Oss®]

• 00814913024301: AOSN200LV
• 00814913024295: AOSN100LV
• 00814913024288: AOSN050LV
• 00814913024271: AOSN025LV
• 00814913024264: AOSN010LV
• 00814913024257: AOSN200SV
• 00814913024240: AOSN100SV
• 00814913024233: AOSN050SV
• 00814913024226: AOSN025SV
• 00814913024219: AOSN010SV