O-SPOT

GUDID 00815137020391

Mole Markers, 1mm uniform low-density see-through ring

Beekley Corporation

Radiographic image marker, manual

• Primary Device ID: 00815137020391
• NIH Device Record Key: 1034d05c-4356-439b-a610-00a93bba177d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-SPOT
• Version Model Number: 652
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 58
• 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	00815137020391 [Primary]
GS1	10815137020398 [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 [O-SPOT]

• 00815137021947: Mole Markers, 1mm uniform ultra-sheer see-through ring, pinch-free material
• 00815137021831: Mole Markers, 1mm uniform low-density see-through ring, pinch free material
• 00815137021787: Mole Markers, 1mm uniform low-density see-through ring
• 00815137021732: Mole Markers, 1.6mm semi-radiolucent ring
• 00815137020551: Mole Markers, 1mm uniform ultra-sheer see-through ring, pinch-free material
• 00815137020445: Mole Markers, 1mm uniform low-density see-through ring, pinch free material
• 00815137020391: Mole Markers, 1mm uniform low-density see-through ring
• 00815137020346: Mole Markers, 1.6mm semi-radiolucent ring