CS Helmet Angle Pads Set - Disposable HAP-01D

GUDID 05060624122798

CARE SURGICAL LIMITED

Operating table patient pressure distribution pad, single-use

• Primary Device ID: 05060624122798
• NIH Device Record Key: 0c7b1ce1-7966-4c64-832c-c5b27166bc0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS Helmet Angle Pads Set - Disposable
• Version Model Number: HAP-01D
• Catalog Number: HAP-01D
• Company DUNS: 221313015
• Company Name: CARE SURGICAL LIMITED
• Device Count: 5
• 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: 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	05060624122798 [Unit of Use]
GS1	05060624122804 [Primary]

FDA Product Code

• FMP: Protector, Skin Pressure

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: 2025-03-24
• Device Publish Date: 2025-03-14

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
• 05060624120596 - CS Spine Frame Set: 2025-04-07 Set consists of: (CSM2606-1, CSM2709, CSM2717, CSM2712, CSM2712-4)