CS Prone Plus Helmet CSM2565-1

GUDID 05060624120169

CARE SURGICAL LIMITED

Patient positioner base plate

• Primary Device ID: 05060624120169
• NIH Device Record Key: c6f6a41e-6d1f-493f-8b91-759122f03502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS Prone Plus Helmet
• Version Model Number: CSM2565-1
• Catalog Number: CSM2565-1
• Company DUNS: 221313015
• Company Name: CARE SURGICAL LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	05060624120169 [Primary]

FDA Product Code

• CCX: Support, Patient Position

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: 2025-04-07
• Device Publish Date: 2025-03-28

Devices Manufactured by CARE SURGICAL LIMITED

• 05060624120046 - CS Chest Support: 2025-04-07
• 05060624120114 - CS Prone Head Support System: 2025-04-07
• 05060624120121 - CS Prone Plus Head Support System: 2025-04-07
• 05060624120138 - CS Adjustable Mirror System: 2025-04-07
• 05060624120145 - CS Adjustable Mirror Plus System: 2025-04-07
• 05060624120152 - CS Prone Helmet: 2025-04-07
• 05060624120169 - CS Prone Plus Helmet: 2025-04-07
• 05060624120169 - CS Prone Plus Helmet: 2025-04-07
• 05060624120596 - CS Spine Frame Set: 2025-04-07 Set consists of: (CSM2606-1, CSM2709, CSM2717, CSM2712, CSM2712-4)