Bongold Bone Graft Material Particles

GUDID 06953122702281

Beijing Allgens Medical Science & Technology Co., Ltd.

Bone grafting cannula

• Primary Device ID: 06953122702281
• NIH Device Record Key: 98ed6a83-47be-4927-8606-cbae4e8894a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bongold Bone Graft Material
• Version Model Number: Gr-1
• Catalog Number: Particles
• Company DUNS: 528729422
• Company Name: Beijing Allgens Medical Science & Technology Co., 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: false
• 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	06953122702281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141725

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-10-27

On-Brand Devices [Bongold Bone Graft Material]

• 06953122702304: Gr-3
• 06953122702298: Gr-2
• 06953122702281: Gr-1
• 06953122702274: Re-7
• 06953122702267: Re-6
• 06953122702250: Re-5
• 06953122702243: Re-4
• 06953122702236: Re-3
• 06953122702212: Re-2
• 06953122702205: Re-1
• 06953122702199: Co-5
• 06953122702182: Co-4
• 06953122702175: Co-3
• 06953122702168: Co-2
• 06953122702151: Co-1