FDA.report

KLARITY MEDICAL

Primary DI
00817355024083
Brand
KLARITY MEDICAL
Company
KLARITY MEDICAL PRODUCTS, LLC
Model
R550-CVHS1
Device description
Custom Rounded Corner Head & Shoulder Shell Cushion™, 46x45 cm for Eberhard Medizintechnik
Published
2019-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817355024083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355024083008173550240838173550240830817355024083

GMDN Terms

TermDefinition
Patient positioning foam mould kitA collection of devices designed to facilitate the delivery of a self-hardening foam that is either poured or injected into a bag or container placed around a patient. After hardening, the foam and the bag/container form a patient-specific (custom-made) mould of that anatomy. The mould can be whole body or only selected body parts and are commonly used to help ensure adequate positioning and immobilization of the patient during radiation therapy treatments and to facilitate reproducible positioning for serial treatments.

Sterilization Methods

Method

Regulatory Flags

DUNS number
034824691
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
true
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 DIBrandModelCatalogPublished
00840510401108KLARITY MEDICALR7512-70C2026-03-23
00840510401115KLARITY MEDICALR7512-50C2026-03-23
00840510401122KLARITY MEDICALR7512-35C2026-03-23
00840510401139KLARITY MEDICALR7512-47C2026-03-23
00817355025394KLARITY MEDICALR421U2025-10-30
00840510400088KLARITY MEDICALR625-NFCF92026-03-17
00840510401085KLARITY MEDICALKRA3-471122026-03-16
00840510401092KLARITY MEDICALKRA3-36462026-03-16
00817355028111KLARITY MEDICALRE-630ESCF2026-03-13
00817355025806KLARITY MEDICALPS-2022A2026-03-12
00817355025820KLARITY MEDICALPS-3200A2026-03-12
00817355025868KLARITY MEDICALPS-3201A2026-03-12
00817355026247KLARITY MEDICALPS-2400A2026-03-12
00840510401054KLARITY MEDICALGR7504-A30C2026-03-12
00840510401061KLARITY MEDICALRG-BHS-A2436F2026-03-12
00840510401078KLARITY MEDICALRG-BHS-8A24362026-03-12
00817355025622KLARITY MEDICALRE-7EC2022-01-05
00817355021976KLARITY MEDICALP-3201A2026-03-06
00817355025790KLARITY MEDICALPB-2412A2026-03-06
00817355025813KLARITY MEDICALP-3205A2026-03-06

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00840510401122KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401139KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
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