Pediatric Face Guard Cushion - Box of 10 925.PFGC-BX10

GUDID 05060624126901

Prone Small Face Cushion - Supports patients' faces in the prone position.

CARE SURGICAL LIMITED

Operating table patient pressure distribution pad, single-use

• Primary Device ID: 05060624126901
• NIH Device Record Key: 099165b4-0839-4ab1-9da4-8ff07ba42cfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Face Guard Cushion - Box of 10
• Version Model Number: 925.PFGC-BX10
• Catalog Number: 925.PFGC-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	05060624126901 [Unit of Use]
GS1	05060624126918 [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: 2025-12-31
• Device Publish Date: 2025-12-23

Devices Manufactured by CARE SURGICAL LIMITED

• 05060624127182 - CS Easy Prone (170 mm) - Grey: 2026-02-03
• 05060624127199 - CS Easy Prone (170 mm) - Chest only (Grey): 2026-02-03
• 05060624127342 - CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients: 2026-02-03
• 05060624127366 - CS Easy Prone (150 mm) - Grey: 2026-02-03
• 05060624127373 - CS Easy Prone (150 mm) - Chest only (Grey): 2026-02-03
• 05060624127397 - CS Easy Prone (150 mm) - Pelvis Only (Grey): 2026-02-03
• 05060624127403 - CS Easy Prone (170 mm) - Pelvis only (Grey): 2026-02-03
• 05060624127458 - CS Easy Prone (200 mm) - Grey: 2026-02-03