QuickScan Pads PB-30-1

GUDID 00853818007156

QuickScan Pads, 1 Jar

PRECISION BIOMETRICS INC

Electrode conductive medium

• Primary Device ID: 00853818007156
• NIH Device Record Key: 28d2e04b-6c07-4b45-8332-7d9d16758772
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickScan Pads
• Version Model Number: PB-30
• Catalog Number: PB-30-1
• Company DUNS: 362997926
• Company Name: PRECISION BIOMETRICS INC
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	00853818007156 [Primary]
GS1	00853818007163 [Package]; Package: Pack [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123399

FDA Product Code

• IKN: Electromyograph, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-12-07

Devices Manufactured by PRECISION BIOMETRICS INC

• 00853818007477 - MyoVision Software: 2022-11-18 Software
• 00853818007460 - MyoVision Wirefree System: 2021-05-25 VisionHUB with DynaVision Dynamic sEMG
• 00853818007422 - SERIES-5 MyoVision Full System: 2021-03-08 VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner
• 00853818007439 - SERIES-5 MyoVision ScanVision: 2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanner
• 00853818007446 - SERIES-5 MyoVision ScanVision: 2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanners
• 00853818007453 - SERIES-5 MyoVision FlexVision System: 2021-03-08 SERIES-5 VisionHUB with FlexVision Inclinometers
• 00853818007415 - MyoVision Wirefree System: 2021-01-13 VisionHub with FlexVision Inclinometers and DynaVision Dynamic sEMG
• 00853818007330 - USB Charger: 2020-02-06 USB Wall Charger