Fixture Lab Analog

GUDID 00810112921571

Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua)

Inosys, Inc.

Dental implant analog

• Primary Device ID: 00810112921571
• NIH Device Record Key: af2bccef-ec79-4247-825f-fc56a2f46f75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixture Lab Analog
• Version Model Number: PBFAN M35H
• 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: true
• 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	00810112921571 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

[00810112921571]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [Fixture Lab Analog]

• 00810112921595: Biotem AR FIXTURE LAB ANALOG 4.0Ø, 4.5Ø, 5.0Ø
• 00810112921588: Biotem AR FIXTURE LAB ANALOG 3.7Ø(Regular)
• 00810112921571: Biotem AR FIXTURE LAB ANALOG 3.4Ø(aqua)