Osseofuse OnePLUS Dental Implant

GUDID 00858249007478

OSSEOFUSE INTERNATIONAL, INC.

Dental implant system

• Primary Device ID: 00858249007478
• NIH Device Record Key: cc4d473b-6f7f-4d64-bab7-e56ca7074c1d
• Commercial Distribution Discontinuation: 2022-11-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Osseofuse OnePLUS Dental Implant
• Version Model Number: OPF3010
• Company DUNS: 080694564
• Company Name: OSSEOFUSE INTERNATIONAL, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00858249007478 [Primary]

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-10
• Device Publish Date: 2020-05-27

On-Brand Devices [Osseofuse OnePLUS Dental Implant]

• 00810044840476: OPF5214
• 00810044840469: OPF5213
• 00810044840452: OPF5211
• 00810044840445: OPF4514
• 00810044840438: OPF4513
• 00810044840421: OPF4511
• 00810044840414: OPF3714
• 00810044840407: OPF3713
• 00810044840391: OPF3711
• 00810044840384: OPF3014
• 00810044840377: OPF3013
• 00810044840360: OPF3011
• 00858249007478: OPF3010
• 00854989008355: OPF4510
• 00854989008294: OPF3710
• 00810044841404: OPF3008
• 00810044841398: OPF5210