FDA.reportPublic FDA data

Face Cushy | C-Flex | Box of 10

Primary DI
05060624128998
Brand
Face Cushy | C-Flex | Box of 10
Company
CARE SURGICAL LIMITED
Model
925.FGC-CFLEX-BX10
Catalog number
925.FGC-CFLEX-BX10
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
05060624128998PrimaryGS10
05060624128981Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624128998050606241289985060624128998
05060624128981050606241289815060624128981

Regulatory Flags#

DUNS number
221313015
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060624128974Face Cushy | Box of 10925.FGC-BX10925.FGC-BX102026-11-03
05060624129018Face Cushy | Pediatric | Box of 10925.PFGC-BX10925.PFGC-BX102026-11-03
05060624129049Face Cushy Set (Helmet + Mirror)925.FGS925.FGS2026-11-03
05060624125591Face Guard Cushion – Box of 10925.FGC-BX10925.FGC-BX102024-07-22
05060624127007CS Mayfield / Doro AdaptorsCSM3048CSM30482026-08-07
05060624129087CS Plexus Wedges (Pair)CSM2908CSM29082026-05-04
05060624128332Face Guard Cushion C-Flex925.FGC-CFLEX925.FGC-CFLEX2026-05-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060624128974Face Cushy | Box of 10CARE SURGICAL LIMITEDFMP2026-11-03
05060624129018Face Cushy | Pediatric | Box of 10CARE SURGICAL LIMITEDFMP2026-11-03
00089904011510Action®ACTION PRODUCTS, INC.FMP2026-10-14
00089904011527Action®ACTION PRODUCTS, INC.FMP2026-10-14
00850018561037Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561044Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561051Gel-E DonutINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561068SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561075SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00850018561082SquishonINTERNATIONAL BIOMEDICAL, LTD.FMP2026-10-13
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ Offloading InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20