Universal Speed

GUDID 08800118631712

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118631712
• NIH Device Record Key: 97dd864e-84ca-4819-ba35-be8f0a0f801e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Speed
• Version Model Number: W ML UVS BL1 30
• 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	08800118631712 [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: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [Universal Speed]

• 08800118631897: W ML UVS BL3 30
• 08800118631880: W ML UVS BL3 28
• 08800118631873: W ML UVS BL3 25
• 08800118631866: W ML UVS BL3 22
• 08800118631859: W ML UVS BL3 20
• 08800118631842: W ML UVS BL3 18
• 08800118631835: W ML UVS BL3 16
• 08800118631828: W ML UVS BL3 14
• 08800118631811: W ML UVS BL3 12
• 08800118631804: W ML UVS BL2 30
• 08800118631798: W ML UVS BL2 28
• 08800118631781: W ML UVS BL2 25
• 08800118631774: W ML UVS BL2 22
• 08800118631767: W ML UVS BL2 20
• 08800118631750: W ML UVS BL2 18
• 08800118631743: W ML UVS BL2 16
• 08800118631736: W ML UVS BL2 14
• 08800118631729: W ML UVS BL2 12
• 08800118631712: W ML UVS BL1 30
• 08800118631705: W ML UVS BL1 28
• 08800118631699: W ML UVS BL1 25
• 08800118631682: W ML UVS BL1 22
• 08800118631675: W ML UVS BL1 20
• 08800118631668: W ML UVS BL1 18
• 08800118631651: W ML UVS BL1 16
• 08800118631644: W ML UVS BL1 14
• 08800118631637: W ML UVS BL1 12
• 08800118631620: W ML UVS D4 30
• 08800118631613: W ML UVS D4 28
• 08800118631606: W ML UVS D4 25
• 08800118631590: W ML UVS D4 22
• 08800118631583: W ML UVS D4 20
• 08800118631576: W ML UVS D4 18
• 08800118631569: W ML UVS D4 16
• 08800118631552: W ML UVS D4 14
• 08800118631545: W ML UVS D4 12
• 08800118631538: W ML UVS D3 30
• 08800118631521: W ML UVS D3 28
• 08800118631514: W ML UVS D3 25
• 08800118631507: W ML UVS D3 22
• 08800118631491: W ML UVS D3 20
• 08800118631484: W ML UVS D3 18
• 08800118631477: W ML UVS D3 16
• 08800118631460: W ML UVS D3 14
• 08800118631453: W ML UVS D3 12
• 08800118631446: W ML UVS D2 30
• 08800118631439: W ML UVS D2 28
• 08800118631422: W ML UVS D2 25
• 08800118631415: W ML UVS D2 22
• 08800118631408: W ML UVS D2 20