OrthoSPOTS Packets

GUDID 00815137020162

MRI Skin Markers for Orthopedic Imaging, 0.75cm Radiance filled packet

Beekley Corporation

Radiographic image marker, manual

• Primary Device ID: 00815137020162
• NIH Device Record Key: 7bae8ca5-ae8c-47f5-93dd-c6be8029be08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoSPOTS Packets
• Version Model Number: 186
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 40
• 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	00815137020162 [Primary]
GS1	10815137020169 [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 [OrthoSPOTS Packets]

• 00815137021497: MRI Skin Markers for Orthopedic Imaging, 0.75cm Radiance filled packet
• 00815137020162: MRI Skin Markers for Orthopedic Imaging, 0.75cm Radiance filled packet