FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00817355027084
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
R550-U9
Device description
Klarity Cushion™ customizable mold 38cm x 23cm, 37mm thickness
Published
2022-11-09
Public version status
Update
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
00817355027084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355027084008173550270848173550270840817355027084

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
00817355025400KLARITY MEDICALR-ET91-32422026-10-28
00817355025127KLARITY MEDICALRB-ESH3-3210CN2026-10-26
00840510401672KLARITY MEDICALGR7661-A21C2026-10-23
00840510401689KLARITY MEDICALGR7661-A22C2026-10-23
00817355029323KLARITY MEDICALRE-7A2025-07-29
00840510401665KLARITY MEDICALR616-AE5-SP2026-10-21
00840510401627KLARITY MEDICALR550-OA12026-10-05
00840510401634KLARITY MEDICALR550-OA22026-10-05
00817355027527KLARITY MEDICALR7800-VBI2023-11-20
00817355025769KLARITY MEDICALRG460C32022-03-16
00817355025776KLARITY MEDICALRG460CH32022-03-16
00817355025370KLARITY MEDICALRCLG-ESH3-2412CMB2021-07-01
00817355023994KLARITY MEDICALRCLG-ESH3-2412CN2019-05-16
00817355022201Klarity MedicalRLG-ESH3-2412CN2016-12-05
00817355022393Klarity MedicalRLG-ELH-2412CN2017-01-27
00817355022409Klarity MedicalRLG-ELS-2412CN2017-01-27
00817355022447Klarity MedicalRLG-ESH2-2412C2017-03-20
00817355022850Klarity MedicalRLG-ESH1-2412C2017-07-17
00840510401511KLARITY MEDICALR7628-15C2026-08-11
00840510401603KLARITY MEDICALR7529-61C2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21