FDA.reportPublic FDA data

Cover Multipad

Primary DI
07640178061477
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
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480151859
Device count
100
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
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

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