R-SPOT

GUDID 10815137022163

Right skin markers for MRI

Beekley Corporation

Radiological image marker, noninvasive, single-use

• Primary Device ID: 10815137022163
• NIH Device Record Key: e3733f3c-2a0d-4e3f-9975-77e5924acef5
• Commercial Distribution Discontinuation: 2024-08-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: R-SPOT
• Version Model Number: 134
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 25
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815137022166 [Primary]
GS1	10815137022163 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-30
• Device Publish Date: 2023-01-09

On-Brand Devices [R-SPOT]

• 00815137021374: Disposable Cassette Markers for General Imaging, lead-free radiopaque R
• 00815137020049: Disposable Cassette Markers for General Imaging, lead-free radiopaque R
• 10815137022163: Right skin markers for MRI