COMPACTOR AND OSTEOTOME DRILLS KIT

GUDID 08435389806004

BIOTECHNOLOGY INSTITUTE SL

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

• Primary Device ID: 08435389806004
• NIH Device Record Key: 935e15c2-2c38-4024-ac6c-8a8208260dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPACTOR AND OSTEOTOME DRILLS KIT
• Version Model Number: KEXCO
• Company DUNS: 461665312
• Company Name: BIOTECHNOLOGY INSTITUTE SL
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389806004 [Primary]

FDA Product Code

• OFY: Dental Implant Surgical Tray

Sterilization

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

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

[08435389806004]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [COMPACTOR AND OSTEOTOME DRILLS KIT]

• 08435389806004: KEXCO
• 08435389825258: KEXCO