Faset FA.IC6045

GUDID 08800039825405

Cannulated Tap 4.5

DIOMEDICAL CO.,LTD.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 08800039825405
• NIH Device Record Key: 043af8fb-e4fa-45f6-bee0-6569abb49080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faset
• Version Model Number: A
• Catalog Number: FA.IC6045
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039825405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180729

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

[08800039825405]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2019-02-08

On-Brand Devices [Faset]

• 08800039825306: K Wire Holder
• 08800039821735: DTS Dilator M
• 08800039821728: DTS Guide
• 08800039825375: Cannulated Drill Bit 4.0
• 08800039825368: Cannulated Drill Bit 3.5
• 08800113952522: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 60 mm
• 08800113952515: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 55 mm
• 08800113952508: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 50 mm
• 08800113952492: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 45 mm
• 08800113952485: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 40 mm
• 08800113952478: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 35 mm
• 08800113952461: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 30 mm
• 08800113952454: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 28 mm
• 08800113952447: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 27 mm
• 08800113952430: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 25 mm
• 08800113952423: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 23 mm
• 08800113952416: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 21 mm
• 08800113952409: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 5.0 x 20 mm
• 08800113952393: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 60 mm
• 08800113952386: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 55 mm
• 08800113952379: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 50 mm
• 08800113952362: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 45 mm
• 08800113952355: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 40 mm
• 08800113952348: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 35 mm
• 08800113952331: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 30 mm
• 08800113952324: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 28 mm
• 08800113952317: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 27 mm
• 08800113952300: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 25 mm
• 08800113952294: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 23 mm
• 08800113952287: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 21 mm
• 08800113952270: FaSet - Dual Thread Type -Lag Faset Screw Thread (Single & Self Tapping) 4.5 x 20 mm
• 08800039825290: Awl, Cannulated
• 08800039825443: Tap 5.5
• 08800039825436: Tap 5.0
• 08800039825429: Cannulated Tap 5.5
• 08800039825412: Cannulated Tap 5.0
• 08800039825405: Cannulated Tap 4.5
• 08800039820356: Tap 4.5