FDA.reportPublic FDA data

CT Gantry Cover

Primary DI
07640178062016
Brand
CT Gantry Cover
Company
Pearl Technology AG
Model
CT Gantry Cover S90
Catalog number
1309
Device description
Reusable hygienic device shield for CT devices during invasive and non-invasive procedures to protect the CT device from penetrating fluids. Covers the lower half of the CT gantry. May only be used by medical personnel. Non-sterile and not to be used in the sterile field.
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178062016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178062016076401780620167640178062016

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, reusableA noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity, of a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480151859
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640178060753MultipadMultipad Research Kit50042025-12-17
07640178060760PearlFitPearlFit Forehead Kit50052025-12-17
07640178060852PearlFitPearlFit Wedge 56x50x25 NUC Vac11862025-12-17
07640178060906PearlFitPearlFit Wedge 56x50x25 blue11912025-12-17
07640178060982ProFoamProFoam Table Mat 200x55x3 DS11992025-12-17
07640178060999ProFoamProFoam Table Mat 180x50x3 DS12002025-12-17
07640178061002ProFoamProFoam Table Mat 200x55x3 DSR12012025-12-17
07640178061019ProFoamProFoam Table Mat 180x50x3 DSR12022025-12-17
07640178061446CT Gantry CoverCT Gantry Cover C3312312025-12-17
07640178061736CT Gantry CoverCT Gantry Cover C30712712025-12-17
07640178061750ProFoamProFoam Wedge Inclination 1512732025-12-17
07640178061767ProFoamProFoam Wedge Inclination 3012742025-12-17
07640178061774ProFoamProFoam Wedge Inclination 4012752025-12-17
07640178061781ProFoamProFoam Wedge Inclination Kit50182025-12-17
07640178061804ProBeltProBelt 100 T5 V12782025-12-17
07640178061828CT Table CoverCT Table Cover 2050 G12672025-12-17
07640178061835CT Table CoverCT Table Cover 17012802025-12-17
07640178061842CT Table CoverCT Table Cover 20012812025-12-17
07640178061859ProFoamProFoam Table Mat 240x60x3 DSRG12822025-12-17
07640178061866ProFoamProFoam Table Mat 240x60x3 DSG12832025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PCURBELL MEDICAL PRODUCTS, INC.FMW2026-04-08
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMW2026-01-15
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850056748315FORWARD APLS Surgery SoakerINTEGRATED MEDCRAFT LLCFMW2025-11-06
00850045714529Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20
00850045714543Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20