Razor / MegaPlus

GUDID 08800118613039

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118613039
• NIH Device Record Key: 7043931b-f7b0-4654-97b9-6c6fcdab5a7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Razor / MegaPlus
• Version Model Number: W 800 Pure 12
• Company DUNS: 694821663
• Company Name: U&C International Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800118613039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191902

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-01
• Device Publish Date: 2022-02-21

On-Brand Devices [Razor / MegaPlus]

• 08800118600992: W 800 A0 16
• 08800118600985: W 800 A0 14
• 08800118600978: W 800 A0 12
• 08800118600961: W 800 A0 10
• 08800118600954: W 1100 ML 25
• 08800118600947: W 1100 ML 22
• 08800118600930: W 1100 ML 20
• 08800118600923: W 1100 ML 18
• 08800118600916: W 1100 ML 16
• 08800118600909: W 1100 ML 14
• 08800118600893: W 1100 ML 12
• 08800118600879: W 1100 A4 25
• 08800118600862: W 1100 A4 22
• 08800118600855: W 1100 A4 20
• 08800118600848: W 1100 A4 18
• 08800118600831: W 1100 A4 16
• 08800118600824: W 1100 A4 14
• 08800118600817: W 1100 A4 12
• 08800118600800: W 1100 A4 10
• 08800118600794: W 1100 A3 25
• 08800118600787: W 1100 A3 22
• 08800118600770: W 1100 A3 20
• 08800118600763: W 1100 A3 18
• 08800118600756: W 1100 A3 16
• 08800118600749: W 1100 A3 14
• 08800118600732: W 1100 A3 12
• 08800118600725: W 1100 A3 10
• 08800118600718: W 1100 A2 25
• 08800118600701: W 1100 A2 22
• 08800118600695: W 1100 A2 20
• 08800118600688: W 1100 A2 18
• 08800118600671: W 1100 A2 16
• 08800118600664: W 1100 A2 14
• 08800118600657: W 1100 A2 12
• 08800118600640: W 1100 A2 10
• 08800118600633: W 1100 A1 25
• 08800118600626: W 1100 A1 22
• 08800118600619: W 1100 A1 20
• 08800118600602: W 1100 A1 18
• 08800118600596: W 1100 A1 16
• 08800118600589: W 1100 A1 14
• 08800118600572: W 1100 A1 12
• 08800118600565: W 1100 A1 10
• 08800118600558: W 1100 A0 25
• 08800118600541: W 1100 A0 22
• 08800118600534: W 1100 A0 20
• 08800118600527: W 1100 A0 18
• 08800118600510: W 1100 A0 16
• 08800118600503: W 1100 A0 14
• 08800118600497: W 1100 A0 12