KLARITY MEDICAL

Primary DI
00840510401016
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
R550-U12
Device description
Klarity Cushion™ customizable mold 30cm x 23cm, 70mm thickness with 106mm bump
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132124000KLARITY VACUUM BAG, KLARITY MOLD CUSHIONKlarity Medical Products, LLC2013-11-01IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840510401016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840510401016008405104010168405104010160840510401016

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
034824691
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840510401559KLARITY MEDICALR624-AIRCF012026-08-25
00840510401450KLARITY MEDICALR7253-10NHC2026-08-03
00840510401443KLARITY MEDICALR7201-06C2026-07-24
00840510401436KLARITY MEDICALR550-L32026-07-22
00840510401412KLARITY MEDICALR7703-85NHC2026-07-08
00840510401429KLARITY MEDICALR7527-62C2026-07-08
00840510401382KLARITY MEDICALR7509-80C2026-06-23
00840510401399KLARITY MEDICALR7530-25C2026-06-23
00840510401405KLARITY MEDICALR7540-56C2026-06-23
00840510401375KLARITY MEDICALR7524-120BBC2026-06-22
00840510401368KLARITY MEDICALRKB-3010VT2026-06-09
00840510401351KLARITY MEDICALR610-ND2-1CF2026-06-08
00840510401276KLARITY MEDICALR550-LBS2026-05-29
00840510400392KLARITY MEDICALR550-LB42025-10-28
00840510401320KLARITY MEDICALGR7103S1-A01.5C2026-06-03
00840510401344KLARITY MEDICALGR7103S2-A02C2026-06-03
00840510401283KLARITY MEDICALR616-HT22026-06-01
00840510401290KLARITY MEDICALR624-SCF1-62026-06-01
00840510401306KLARITY MEDICALR624-SCF1-82026-06-01
00840510401313KLARITY MEDICALRE-7B2026-06-01

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