FDA.reportPublic FDA data

ProBelt 200 J10

Primary DI
07640178061408
Brand
ProBelt 200 J10
Company
Pearl Technology AG
Model
ProBelt 200 J10
Catalog number
1241
Device description
Universal patient positioning belt for MR and CT imaging.
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXHCradle, Patient, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178061408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178061408076401780614087640178061408

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
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
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
00850043319153Hyperfine Foam Back PadHyperfine Operations, Inc.KXH2026-05-26
07640178060753MultipadPearl Technology AGKXH2025-12-17
07640178060760PearlFitPearl Technology AGKXH2025-12-17
07640178060852PearlFitPearl Technology AGKXH2025-12-17
07640178060906PearlFitPearl Technology AGKXH2025-12-17
07640178060982ProFoamPearl Technology AGKXH2025-12-17
07640178060999ProFoamPearl Technology AGKXH2025-12-17
07640178061002ProFoamPearl Technology AGKXH2025-12-17
07640178061019ProFoamPearl Technology AGKXH2025-12-17
07640178061750ProFoamPearl Technology AGKXH2025-12-17
07640178061767ProFoamPearl Technology AGKXH2025-12-17
07640178061774ProFoamPearl Technology AGKXH2025-12-17
07640178061781ProFoamPearl Technology AGKXH2025-12-17
07640178061804ProBeltPearl Technology AGKXH2025-12-17
07640178061859ProFoamPearl Technology AGKXH2025-12-17
07640178061866ProFoamPearl Technology AGKXH2025-12-17
07640178061873ProFoamPearl Technology AGKXH2025-12-17
07640178061880ProFoamPearl Technology AGKXH2025-12-17
07640178061897ProBeltPearl Technology AGKXH2025-12-17
07640178061903ProFoamPearl Technology AGKXH2025-12-17
07640178061910ProFoamPearl Technology AGKXH2025-12-17
07640178062085ProFoamPearl Technology AGKXH2025-12-17
07640178062092ProFoamPearl Technology AGKXH2025-12-17
07640178062108ProFoamPearl Technology AGKXH2025-12-17
07640178062115ProFoamPearl Technology AGKXH2025-12-17
07640178062122ProFoamPearl Technology AGKXH2025-12-17
07640178062139ProFoamPearl Technology AGKXH2025-12-17
07640178062146ProFoamPearl Technology AGKXH2025-12-17
07640178062153ProFoamPearl Technology AGKXH2025-12-17
07640178062078pearltecPearl Technology AGKXH2025-07-28