Face Guard Helmet 925.FGH

GUDID 05060624125621

Helmet for use in the prone position. The helmet holds the Face Guard Cushion to maintain it's integrity throughout prone procedures.

CARE SURGICAL LIMITED

Patient positioner base plate

• Primary Device ID: 05060624125621
• NIH Device Record Key: a0df5f00-9002-40a1-821d-d7e9aed2cf51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Guard Helmet
• Version Model Number: 925.FGH
• Catalog Number: 925.FGH
• 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	05060624125621 [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: 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