FDA.reportPublic FDA data

Cover Multipad

Primary DI
07640178060067
Brand
Cover Multipad
Company
Pearl Technology AG
Model
Cover Multipad
Catalog number
1101
Device description
Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging.
Published
2022-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178060067PrimaryGS10
07640178061477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178060067076401780600677640178060067
07640178061477076401780614777640178061477

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA 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 may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+41435350840info@pearl-technology.ch

Regulatory Flags#

DUNS number
480151859
Device count
100
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
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10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
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10889483602911AirLife™AirLife Finland OyKME2025-04-17
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10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08
16931918123400AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177564AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177984AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
16931918115214HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918121987HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918129372HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918149158HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11