INTREPED Extraction Kit 01-00006

GUDID 00850055649705

The INTREPED Extraction Kit includes instruments and tray for implant explant.

Auxano Medical LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00850055649705
• NIH Device Record Key: 6dde06a0-23b8-46b8-9102-39b8cc410339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTREPED Extraction Kit
• Version Model Number: 01-00006
• Catalog Number: 01-00006
• Company DUNS: 119185571
• Company Name: Auxano Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net
• Phone: 4402622000
• Email: CS@AuxanoMedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850055649705 [Primary]

FDA Product Code

• HWK: Trephine

Sterilization

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

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

[00850055649705]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-20
• Device Publish Date: 2025-01-10

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• 00850055649330 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED Auxiliary Caddy Assembly
• 00850055649378 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED 08 Tap (Beta)
• 00850055649385 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED 09 Tap (Beta)
• 00850055649392 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED 10 Tap (Beta)
• 00850055649408 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED 08 Driver
• 00850055649415 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED 10 Driver
• 00850055649422 - INTREPED, Intraosseous Fusion Device: 2025-04-01 INTREPED 08 Sizer