CS Prone Smart Helmet CSM2561-1

GUDID 05060624123580

CARE SURGICAL LIMITED

Patient positioner base plate

• Primary Device ID: 05060624123580
• NIH Device Record Key: 64bffc97-36e3-47ec-9318-fd97d930da65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS Prone Smart Helmet
• Version Model Number: CSM2561-1
• Catalog Number: CSM2561-1
• 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	05060624123580 [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

• 05060624125157 - CS Extension Thigh Supports (Pair) - Grey: 2025-08-13
• 05060624125164 - CS Extension Hip Support - Grey: 2025-08-13
• 05060624125171 - CS Extension Thigh Support - Left (Grey): 2025-08-13
• 05060624125188 - CS Extension Thigh Support - Right (Grey): 2025-08-13
• 05060624127151 - CS Spine Frame Set - Grey: 2025-08-13
• 05060624122279 - CS Pad 3”: 2025-08-12
• 05060624125126 - CS Pad 1” - Grey: 2025-08-12
• 05060624125140 - CS Extension Hip Supports (Pair) - Grey: 2025-08-12