Razor

GUDID 08800118619031

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118619031
• NIH Device Record Key: d01b009b-bb07-4bba-9234-399eb930dc0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Razor
• Version Model Number: W 800 Pure 28
• 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	08800118619031 [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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [Razor]

• 08800118612995: W CAP A0 20
• 08800118612988: W CAP A0 18
• 08800118612971: W CAP A0 16
• 08800118612964: W CAP A0 14
• 08800118612957: W CAP A0 12
• 08800118612940: W CAP A0 10
• 08800118613015: W CAP A0 25
• 08800118613008: W CAP A0 22
• 08800118619154: W 1400 A0 30
• 08800118619147: W 1400 A0 28
• 08800118619130: W 1400 A0 25
• 08800118619123: W 1400 A0 22
• 08800118619116: W 1400 A0 20
• 08800118619109: W 1400 A0 18
• 08800118619093: W 1400 A0 16
• 08800118619086: W 1400 A0 14
• 08800118619079: W 1400 A0 12
• 08800118619062: W 1400 A0 10
• 08800118619055: W 800 Dark 28
• 08800118619048: W 800 Light 28
• 08800118619031: W 800 Pure 28
• 08800118619024: W CAP A0 30
• 08800118619017: W CAP A0 28