primosplint system

GUDID D831PSKIT1

PRIMOTEC LLC

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• Primary Device ID: D831PSKIT1
• NIH Device Record Key: 284096d6-cbe9-4451-a5ac-bf8139bdc404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primosplint system
• Version Model Number: PSKIT1
• Company DUNS: 153454736
• Company Name: PRIMOTEC LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D831PSKIT1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030832

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2021-11-17
• Device Publish Date: 2021-11-09

Devices Manufactured by PRIMOTEC LLC

• D831PS100US1 - Primosplint: 2021-11-17
• D831PS202US0 - primostick: 2021-11-17
• D831PS204US0 - primoglaze: 2021-11-17
• D831PSKIT1 - primosplint system: 2021-11-17
• D831PSKIT1 - primosplint system: 2021-11-17
• D831TI10 - PREMIOtitan: 2020-09-07
• D831TI12 - PREMIOtitan: 2020-09-07
• D831TI135 - PREMIOtitan: 2020-09-07
• D831TI15 - PREMIOtitan: 2020-09-07