Y-SPOT

GUDID 00815137021336

General Imaging/Radiation Therapy Skin Markers, 2.0mm lead-free pellet

Beekley Corporation

Radiographic image marker, manual

• Primary Device ID: 00815137021336
• NIH Device Record Key: e4f82e28-0f66-429b-bb95-87f39304d911
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-SPOT
• Version Model Number: 102S
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 3
• 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	00815137021336 [Primary]
GS1	10815137020015 [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

On-Brand Devices [Y-SPOT]

• 00815137021695: Nipple Markers, 2.0mm lead-free pellet
• 00815137021336: General Imaging/Radiation Therapy Skin Markers, 2.0mm lead-free pellet
• 00815137020308: Nipple Markers, 2.0mm lead-free pellet
• 00815137020018: General Imaging/Radiation Therapy Skin Markers, 2.0mm lead-free pellet