GUDID 00840682138284

USA INSTRUMENTS, INC.

Radiological breast positioner, non-wearable

• Primary Device ID: 00840682138284
• NIH Device Record Key: dab94869-6f80-4ff5-a3b0-e9b6ce412b26
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LATERAL LARGE GRID BREAST BIOPSY PLATE
• Company DUNS: 804517571
• Company Name: USA INSTRUMENTS, 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: true
• Lot Batch: true
• 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	00840682138284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041695

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2017-12-01

Devices Manufactured by USA INSTRUMENTS, INC.

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• 00840682114394 - NA: 2020-03-05
• 00840682114400 - NA: 2020-03-05
• 00840682114547 - NA: 2020-03-05
• 00840682115780 - NA: 2020-03-05