Face Guard Cushion – Box of 10 925.FGC-BX10

GUDID 05060624126925

Prone Face Cushion - Supports patients' faces in the prone position. For use with the Face Guard Set System and other compatible head support systems

CARE SURGICAL LIMITED

Operating table patient pressure distribution pad, single-use

• Primary Device ID: 05060624126925
• NIH Device Record Key: 20c6270a-7891-4d36-ae8c-285aa48cf803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Guard Cushion – Box of 10
• Version Model Number: 925.FGC-BX10
• Catalog Number: 925.FGC-BX10
• Company DUNS: 221313015
• Company Name: CARE SURGICAL LIMITED
• Device Count: 10
• 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	05060624125591 [Primary]
GS1	05060624126925 [Unit of Use]

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: 2024-07-30
• Device Publish Date: 2024-07-22

Devices Manufactured by CARE SURGICAL LIMITED

• 05060624121654 - CS Jackson Comfort Chest Cushion (30mm): 2024-11-06
• 05060624122323 - CS Comfort Cushion Set - 3 piece: 2024-11-06
• 05060624126710 - CS Jackson Covers Hip & Thigh Combo Set: 2024-11-06
• 05060624120862 - CS Jackson Chest Cushion with Hip/Thigh Combo Covers: 2024-11-06
• 05060624120503 - CS Comfort Chest Cushion (60mm): 2024-11-06
• 05060624120510 - CS Comfort Hip and Thigh Cushions (60mm): 2024-11-06
• 05060624120527 - CS Comfort Arm Cushions (Pair): 2024-11-06
• 05060624120541 - CS Comfort Leg Cushion: 2024-11-06