Viceroy V-0101

GUDID 08800039825832

Locking cap

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800039825832
• NIH Device Record Key: 5d7c5f27-8144-414d-a6c4-7f87fd6c18ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viceroy
• Version Model Number: A
• Catalog Number: V-0101
• 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
• 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
• 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
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039825832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122229

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

[08800039825832]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-22
• Device Publish Date: 2020-07-14

On-Brand Devices [Viceroy]

• 08800039826945: Rod 6.0 x 500mm
• 08800039826938: MIS-Rod 6.0 x 95mm
• 08800039826921: MIS-Rod 6.0 x 85mm
• 08800039826914: MIS-Rod 6.0 x 110mm
• 08800039826907: MIS-Rod 6.0 x 100mm
• 08800039826891: MIS-Rod 6.0 x 90mm
• 08800039826884: MIS-Rod 6.0 x 80mm
• 08800039826877: MIS-Rod 6.0 x 75mm
• 08800039826860: MIS-Rod 6.0 x 70mm
• 08800039826853: MIS-Rod 6.0 x 65mm
• 08800039826846: MIS-Rod 6.0 x 60mm
• 08800039826839: MIS-Rod 6.0 x 55mm
• 08800039826822: MIS-Rod 6.0 x 50mm
• 08800039826815: MIS-Rod 6.0 x 45mm
• 08800039826808: MIS-Rod 6.0 x 40mm
• 08800039826792: MIS-Rod 6.0 x 35mm
• 08800039826785: MIS-Long Screw 6.0 Assembly 7.5 x 60mm
• 08800039826778: MIS-Long Screw 6.0 Assembly 7.5 x 55mm
• 08800039826761: MIS-Long Screw 6.0 Assembly 7.5 x 50mm
• 08800039826754: MIS-Long Screw 6.0 Assembly 7.5 x 45mm
• 08800039826747: MIS-Long Screw 6.0 Assembly 7.5 x 40mm
• 08800039826730: MIS-Long Screw 6.0 Assembly 7.5 x 35mm
• 08800039826723: MIS-Long Screw 6.0 Assembly 6.5 x 60mm
• 08800039826716: MIS-Long Screw 6.0 Assembly 6.5 x 55mm
• 08800039826709: MIS-Long Screw 6.0 Assembly 6.5 x 50mm
• 08800039826693: MIS-Long Screw 6.0 Assembly 6.5 x 45mm
• 08800039826686: MIS-Long Screw 6.0 Assembly 6.5 x 40mm
• 08800039826679: MIS-Long Screw 6.0 Assembly 6.5 x 35mm
• 08800039826662: MIS-Long Screw 6.0 Assembly 5.5 x 60mm
• 08800039826655: MIS-Long Screw 6.0 Assembly 5.5 x 55mm
• 08800039826648: MIS-Long Screw 6.0 Assembly 5.5 x 50mm
• 08800039826631: MIS-Long Screw 6.0 Assembly 5.5 x 45mm
• 08800039826624: MIS-Long Screw 6.0 Assembly 5.5 x 40mm
• 08800039826617: MIS-Long Screw 6.0 Assembly 5.5 x 35mm
• 08800039826600: MIS-Long Screw 5.5 Assembly 7.5 x 60mm
• 08800039826594: MIS-Long Screw 5.5 Assembly 7.5 x 55mm
• 08800039826587: MIS-Long Screw 5.5 Assembly 7.5 x 50mm
• 08800039826570: MIS-Long Screw 5.5 Assembly 7.5 x 45mm
• 08800039826563: MIS-Long Screw 5.5 Assembly 7.5 x 40mm
• 08800039826556: MIS-Long Screw 5.5 Assembly 7.5 x 35mm
• 08800039826549: MIS-Long Screw 5.5 Assembly 6.5 x 60mm
• 08800039826532: MIS-Long Screw 5.5 Assembly 6.5 x 55mm
• 08800039826525: MIS-Long Screw 5.5 Assembly 6.5 x 50mm
• 08800039826518: MIS-Long Screw 5.5 Assembly 6.5 x 45mm
• 08800039826501: MIS-Long Screw 5.5 Assembly 6.5 x 40mm
• 08800039826495: MIS-Long Screw 5.5 Assembly 6.5 x 35mm
• 08800039826488: MIS-Long Screw 5.5 Assembly 5.5 x 60mm
• 08800039826471: MIS-Long Screw 5.5 Assembly 5.5 x 55mm
• 08800039826464: MIS-Long Screw 5.5 Assembly 5.5 x 50mm
• 08800039826457: MIS-Long Screw 5.5 Assembly 5.5 x 45mm