BioPlant

GUDID 00841396100031

Multipurpose Dental Bone Grafting Material

Kerr Corporation

Synthetic bone graft

• Primary Device ID: 00841396100031
• NIH Device Record Key: 6580aa44-8382-4e64-8f68-2d5614d8a583
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPlant
• Version Model Number: 216114
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 6
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8005377123
• Email: xxx@xxx.xxx

Device Dimensions

• Weight: 3 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at ambient temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396100031 [Primary]
GS1	10841396100038 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050984

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2018-07-06
• Device Publish Date: 2015-10-15

On-Brand Devices [BioPlant]

• 00841396100048: Multipurpose Dental Bone Grafting Material
• 00841396100031: Multipurpose Dental Bone Grafting Material
• 00841396100024: Multipurpose Dental Bone Grafting Material
• 00841396100017: Multipurpose Dental Bone Grafting Material
• 00841396100000: Multipurpose Dental Bone Grafting Material