X-SPOT

GUDID 00815137020001

General Imaging/Radiation Therapy Skin Markers, 1.5mm lead-free pellet

Beekley Corporation

Radiographic image marker, manual

• Primary Device ID: 00815137020001
• NIH Device Record Key: 0b7f3a4c-1d0f-4e45-a63d-472593689ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-SPOT
• Version Model Number: 101
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 150
• 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	00815137020001 [Primary]
GS1	10815137020008 [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: 2019-07-30
• Device Publish Date: 2019-07-22

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• 00815137021329: General Imaging/Radiation Therapy Skin Markers, 1.5mm lead-free pellet
• 00815137020292: Nipple Markers, 1.5mm lead-free pellet
• 00815137020001: General Imaging/Radiation Therapy Skin Markers, 1.5mm lead-free pellet