Genie Labral Instruments

GUDID 08800071020936

OSTEONIC CO.,Ltd.

Surgical drill guide, reusable

• Primary Device ID: 08800071020936
• NIH Device Record Key: 48e8d6af-7479-49b5-9047-704448169bde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genie Labral Instruments
• Version Model Number: BIS-04225-DG
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• 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	08800071020936 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08800071020936]

Moist Heat or Steam Sterilization

[08800071020936]

Moist Heat or Steam Sterilization

[08800071020936]

Moist Heat or Steam Sterilization

[08800071020936]

Moist Heat or Steam Sterilization

[08800071020936]

Moist Heat or Steam Sterilization

[08800071020936]

Moist Heat or Steam Sterilization

[08800071020936]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [Genie Labral Instruments]

• 08800071020950: BIS-2610-DR
• 08800071020943: BIS-2110-DR
• 08800071020936: BIS-04225-DG