FDA.reportPublic FDA data

Face Cushy Set (Helmet + Mirror)

Primary DI
05060624129049
Brand
Face Cushy Set (Helmet + Mirror)
Company
CARE SURGICAL LIMITED
Model
925.FGS
Catalog number
925.FGS
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
false

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060624129049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624129049050606241290495060624129049

Regulatory Flags#

DUNS number
221313015
Device count
1
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
05060624128998Face Cushy | C-Flex | Box of 10925.FGC-CFLEX-BX10925.FGC-CFLEX-BX102026-11-03
05060624129018Face Cushy | Pediatric | Box of 10925.PFGC-BX10925.PFGC-BX102026-11-03
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
00787551041668LPK10037 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041675LPK10036 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041682SPK10756 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-10-19
00860003986844GENESIS BI-WING XL GEN 3.0Infinitus Medical Technologies LLCCCX2026-10-15
00860014205507PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEMInfinitus Medical Technologies LLCCCX2026-10-15
09421905187794Adept Medical Lateral Support SingleADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187800Adept Medical Lateral Support PairADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187817Adept Medical Lateral Vacuum BraceADEPT MEDICAL LIMITEDCCX2026-10-05
15060797554775NADavid Scott CompanyCCX2026-09-25
00850047863799SurgiLockMedicalock CorporationCCX2026-09-24
00850047863829SurgiLockMedicalock CorporationCCX2026-09-24
00850047863836CerviLockMedicalock CorporationCCX2026-09-24
00749756401739DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-09-18
00848530109783Oxygen AccessorySunset Healthcare Solutions, Inc.CCX2026-09-09
00787551041637SPK11761 Jackson Table KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041644SPK11773 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041651SPK11774 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00851440007902Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CCX2026-07-22
00811836030907TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30