Primus Bone Level Fixture Surgical Full KIT

GUDID 00810112921601

Biotem SURGICAL KIT

Inosys, Inc.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00810112921601
• NIH Device Record Key: 1f9b5079-720b-43ce-b7b4-dd8ed1212b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primus Bone Level Fixture Surgical Full KIT
• Version Model Number: PBSF
• Company DUNS: 101803383
• Company Name: Inosys, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00810112921601 [Primary]

FDA Product Code

• EIL: Gauge, Depth, Instrument, Dental

Sterilization

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

[00810112921601]

Moist Heat or Steam Sterilization

[00810112921601]

Moist Heat or Steam Sterilization

[00810112921601]

Moist Heat or Steam Sterilization

[00810112921601]

Moist Heat or Steam Sterilization

[00810112921601]

Moist Heat or Steam Sterilization

[00810112921601]

Moist Heat or Steam Sterilization

[00810112921601]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

Devices Manufactured by Inosys, Inc.

• 00810112921571 - Fixture Lab Analog: 2022-06-27 Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua)
• 00810112921588 - Fixture Lab Analog: 2022-06-27 Biotem AR FIXTURE LAB ANALOG 3.7Ø(Regular)
• 00810112921595 - Fixture Lab Analog: 2022-06-27 Biotem AR FIXTURE LAB ANALOG 4.0Ø, 4.5Ø, 5.0Ø
• 00810112921120 - PRIMUS Implant System: 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 5.5mm(Cuff:5)
• 00810112921137 - PRIMUS Implant System: 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 5.5mm(Cuff:6)
• 00810112921144 - PRIMUS Implant System: 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 7.0mm(Cuff:1)
• 00810112921151 - PRIMUS Implant System: 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 7.0mm(Cuff:2)
• 00810112921168 - PRIMUS Implant System: 2022-06-23 Biotem AR CEMENTED ABUTMENT(NON-HEX) 4.5Ø X 7.0mm(Cuff:3)