FDA.reportPublic FDA data

Face Guard Cushion C-Flex

Primary DI
05060624128332
Brand
Face Guard Cushion C-Flex
Company
CARE SURGICAL LIMITED
Model
925.FGC-CFLEX
Catalog number
925.FGC-CFLEX
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060624128332PrimaryGS10
05060624128325Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624128332050606241283325060624128332
05060624128325050606241283255060624128325

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, single-useA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a single-use device.

Regulatory Flags#

DUNS number
221313015
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060624129087CS Plexus Wedges (Pair)CSM2908CSM29082026-05-04
05060624123696CS Align Pro Support - Replacement PadsCSM2780CSM27802026-03-23
05060624126970CS Align Pro SupportCSM2781CSM27812026-03-23
05060624127182CS Easy Prone (170 mm) - GreyCSM2918-GCSM2918-G2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CSM2922-GCSM2922-G2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CSM3086CSM30862026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCSM2699-GCSM2699-G2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CSM2920-GCSM2920-G2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CSM2921-GCSM2921-G2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CSM2923-GCSM2923-G2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCSM2919-GCSM2919-G2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CSM2924-GCSM2924-G2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CSM2925-GCSM2925-G2026-01-26
05060624126918Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126901Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126697CS Fixed Blade ClampCSM3043CSM30432025-12-17
05060624126963CS FlexiFinless™ Stirrup Pads (Pair)CSM3053CSM30532025-10-31
05060624127670CS Blade Clamp Plus – EUCSM2767CSM27672025-10-14
05060624125157CS Extension Thigh Supports (Pair) - GreyCSM2744-GCSM2744-G2025-08-05
05060624125164CS Extension Hip Support - GreyCSM2950-GCSM2950-G2025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
00816299013337HoverMatt PROSWedgeHovertech InternationalFMP2026-07-06
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08