Breast Riser CX

GUDID 00814848020195

QUALITY ELECTRODYNAMICS LLC

Radiological breast positioner, non-wearable Radiological breast positioner, non-wearable

• Primary Device ID: 00814848020195
• NIH Device Record Key: 010bd333-8aba-4785-bdde-43b17696112e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breast Riser CX
• Version Model Number: MAC000109
• Company DUNS: 614760119
• Company Name: QUALITY ELECTRODYNAMICS 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: 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	00814848020195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142002

FDA Product Code

• CCX: Support, Patient Position

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: 2019-03-11
• Device Publish Date: 2016-12-09

Devices Manufactured by QUALITY ELECTRODYNAMICS LLC

• 00814848020508 - Shape Coil: 2021-08-30
• 00814848020546 - Shape Coil: 2021-08-30
• 00814848020515 - 2Tx 28Rx Knee Coil: 2021-02-22
• 00814848020423 - Contour 24: 2020-03-05
• 00814848020003 - 18ch T/R Knee Coil: 2020-03-05
• 00814848020010 - Atlas SPEEDER Head/Neck Coil: 2020-03-05
• 00814848020027 - Wrist SPEEDER Coil: 2020-03-05
• 00814848020034 - Tx/Rx Extra Large Knee Coil: 2020-03-05