TomoSPOT

GUDID 00815137021909

Palpable Mass Markers, low-density see-through triangle, pinch-free material

Beekley Corporation

Radiographic image marker, manual

• Primary Device ID: 00815137021909
• NIH Device Record Key: c7b9cbc3-c4e0-4163-9a2b-126392dadfb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TomoSPOT
• Version Model Number: 784S
• 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	00815137021909 [Primary]
GS1	10815137020510 [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 [TomoSPOT]

• 00815137021916: Point of Pain/Non-Palpable Area of Concern Markers, uniform low-density see-through square
• 00815137021909: Palpable Mass Markers, low-density see-through triangle, pinch-free material
• 00815137021893: Scar Markers, low density see-through line, pinch-free material
• 00815137021886: Mole Markers, low-density see-through ring, pinch-free material
• 00815137021879: Nipple Markers, 2.3mm non-metallic pellet, pinch-free material with adhesive free center
• 00815137020520: Point of Pain/Non-Palpable Area of Concern Markers, uniform low-density see-through square
• 00815137020513: Palpable Mass Markers, low-density see-through triangle, pinch-free material
• 00815137020506: Scar Markers, low density see-through line, pinch-free material
• 00815137020490: Mole Markers, low-density see-through ring, pinch-free material
• 00815137020483: Nipple Markers, 2.3mm non-metallic pellet, pinch-free material with adhesive free center