Amiga

GUDID 00815137022135

MRI liquid-filled tube

Beekley Corporation

Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual Radiographic image marker, manual

• Primary Device ID: 00815137022135
• NIH Device Record Key: 17167553-081e-414b-9717-b0b164cfbe1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amiga
• Version Model Number: 721
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815137022135 [Primary]
GS1	10815137022132 [Unit of Use]

FDA Product Code

• JAC: System, X-Ray, Film Marking, Radiographic

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: 2020-08-10
• Device Publish Date: 2020-07-31

Devices Manufactured by Beekley Corporation

• 00815137022227 - CaraClip: 2023-11-21 Wire protector
• 10815137022224 - CaraClip: 2023-11-21 Wire protector
• 10815137022149 - RT-SPOT: 2021-09-15 CT Simulation Skin Markers for Field Borders, Tangents, and Scars
• 00815137022043 - TenderTouch: 2020-08-10 Cushioned tape for thermoplastic masks
• 00815137022050 - TenderTouch: 2020-08-10 Cushioned tape for thermoplastic masks
• 00815137022111 - MR grid: 2020-08-10 MRI liquid-filled grid
• 00815137022128 - MM-SPOT: 2020-08-10 MRI liquid-filled donut
• 00815137022135 - Amiga: 2020-08-10MRI liquid-filled tube
• 00815137022135 - Amiga: 2020-08-10 MRI liquid-filled tube