Faset FA.IC6055

GUDID 08800039825429

Cannulated Tap 5.5

DIOMEDICAL CO.,LTD.

Bone tap, reusable

• Primary Device ID: 08800039825429
• NIH Device Record Key: 6e706523-f510-4308-a04d-e3f3b13d5e69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faset
• Version Model Number: A
• Catalog Number: FA.IC6055
• 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	08800039825429 [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

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

Moist Heat or Steam Sterilization

[08800039825429]

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