FDA.report

ProBelt 140 MRI P

Primary DI
07640178061187
Brand
ProBelt 140 MRI P
Company
Pearl Technology AG
Model
ProBelt 140 MRI P
Catalog number
1219
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

Related Records

Contact Domains

Product Codes

CodeName
KXHCradle, Patient, Radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640178061187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640178061187076401780611877640178061187

GMDN Terms

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

Contacts

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

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