BlueTooth

GUDID 08800118623564

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118623564
• NIH Device Record Key: ae8ee8c9-c646-4544-85db-3df2fbf22482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlueTooth
• Version Model Number: Z BT A1 18
• 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	08800118623564 [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: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [BlueTooth]

• 08800118608554: W BT A3 30
• 08800118608547: W BT A3 28
• 08800118608530: W BT A3 25
• 08800118608523: W BT A3 22
• 08800118608516: W BT A3 20
• 08800118608509: W BT A3 18
• 08800118608493: W BT A3 16
• 08800118608486: W BT A3 14
• 08800118608479: W BT A3 12
• 08800118608462: W BT A3 10
• 08800118608455: W BT A2 30
• 08800118608448: W BT A2 28
• 08800118608431: W BT A2 25
• 08800118608424: W BT A2 22
• 08800118608417: W BT A2 20
• 08800118608400: W BT A2 18
• 08800118608394: W BT A2 16
• 08800118608387: W BT A2 14
• 08800118608370: W BT A2 12
• 08800118608363: W BT A2 10
• 08800118608356: W BT A1 30
• 08800118608349: W BT A1 28
• 08800118608332: W BT A1 25
• 08800118608325: W BT A1 22
• 08800118608318: W BT A1 20
• 08800118608301: W BT A1 18
• 08800118608295: W BT A1 16
• 08800118608288: W BT A1 14
• 08800118608271: W BT A1 12
• 08800118608264: W BT A1 10
• 08800118623786: Z BT A3 30
• 08800118623779: Z BT A3 28
• 08800118623762: Z BT A3 25
• 08800118623755: Z BT A3 22
• 08800118623748: Z BT A3 18
• 08800118623731: Z BT A3 16
• 08800118623724: Z BT A3 14
• 08800118623717: Z BT A3 12
• 08800118623700: Z BT A3 10
• 08800118623694: Z BT A2 30
• 08800118623687: Z BT A2 28
• 08800118623670: Z BT A2 25
• 08800118623663: Z BT A2 22
• 08800118623656: Z BT A2 18
• 08800118623649: Z BT A2 16
• 08800118623632: Z BT A2 14
• 08800118623625: Z BT A2 12
• 08800118623618: Z BT A2 10
• 08800118623601: Z BT A1 30
• 08800118623595: Z BT A1 28