Amiga

GUDID 00815137022135

MRI liquid-filled tube

Beekley Corporation

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

• 00815137022319 - InkRight: 2024-10-31 InkRight Dot Semi-Permanent Tattoos
• 10815137022316 - InkRight: 2024-10-31 InkRight Dot Semi-Permanent Tattoos
• 10815137022323 - InkRight: 2024-10-31 InkRight Crosshair Semi-Permanent Tattoos
• 00815137022258 - RT-SPOT: 2024-09-06 CT Simulation Skin Markers
• 10815137022255 - RT-SPOT: 2024-09-06 CT Simulation Skin Markers
• 10815137022262 - RT-SPOT: 2024-09-06 CT Simulation Skin Markers
• 10815137022279 - RT-SPOT: 2024-09-06 CT Simulation Skin Markers
• 10815137022163 - R-SPOT: 2024-08-30 Right skin markers for MRI