CASE, OUTER, DOUBLE LEVEL

GUDID 00840311262694

CASE, OUTER, DOUBLE LEVEL

Xtant Medical Holdings, Inc.

Device sterilization/disinfection container, reusable

• Primary Device ID: 00840311262694
• NIH Device Record Key: 2dc0b13f-0414-4f4b-af20-d83f4e8e1583
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CASE, OUTER, DOUBLE LEVEL
• Version Model Number: 434-222
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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: false
• 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

Customer Support Contacts

• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM
• Phone: 1-888-886-9354
• Email: CS@XTANTMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311262694 [Primary]

FDA Product Code

• LRP: Tray, Surgical

Sterilization

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

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

[00840311262694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-19
• Device Publish Date: 2026-02-11

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00840311262694 - CASE, OUTER, DOUBLE LEVEL: 2026-02-19CASE, OUTER, DOUBLE LEVEL
• 00840311262694 - CASE, OUTER, DOUBLE LEVEL: 2026-02-19 CASE, OUTER, DOUBLE LEVEL
• 00840311262700 - CASE, OUTER, LID: 2026-02-19 CASE, OUTER, LID
• 00840311247318 - Fortilink: 2026-01-30 TiPlus-TC Inserter, Straight
• 00840311262670 - Cortera Spinal Fixation System: 2025-12-30 Caddy, Set Screw, 5.5-6.0
• 00840311262687 - Cortera Spinal Fixation System: 2025-12-30 Lid, Set Screw, 5.5-6.0
• 00840311262663 - Streamline TL Spinal Fixation System: 2025-12-25 Streamline TL, 8.5mm Long Screw Caddy
• 00840311262632 - Fusion™ Posterior Instrument Set: 2025-12-19 VBR, Graft Funnel
• 00840311244713 - Cortera Spinal Fixation System: 2025-12-18 NAV Instruments Set, ASM