Large U Head Cushions

GUDID B525CO010

Octostop Inc

Radiological whole-body positioner Radiological whole-body positioner

• Primary Device ID: B525CO010
• NIH Device Record Key: f6cd7dd9-2760-4d2f-869e-ccb7c3efce7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large U Head Cushions
• Version Model Number: CO-01
• Company DUNS: 240536946
• Company Name: Octostop Inc
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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
HIBCC	B525CO010 [Primary]

FDA Product Code

• KXH: Cradle, patient, radiologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-11
• Device Publish Date: 2017-11-16

Devices Manufactured by Octostop Inc

• B525BO020 - Standard Board: 2019-03-11
• B525BO030 - Large Board: 2019-03-11
• B525CO010 - Large U Head Cushions: 2019-03-11
• B525CO010 - Large U Head Cushions: 2019-03-11
• B525CO020 - Small U Head Cushions: 2019-03-11
• B525CO030 - L Head and Arm Cushions: 2019-03-11
• B525OC010 - Octogones: 2019-03-11
• B525OC020 - Vertical Support: 2019-03-11
• B525PA030 - Octopaque no Accessories: 2019-03-11