FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00817355025578
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
R461-8VHTF
Device description
Klarity White™ V-type Open Face Head Mask, AccuPerf™, 3.2mm
Published
2026-02-05
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
K022708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022708000KLARITYLarson Products, Inc.2002-11-12IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817355025578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355025578008173550255788173550255780817355025578

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

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
00840510401603KLARITY MEDICALR7529-61C2026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850065937199eMotusEMPNIA INC.IYE2026-09-21
00850065937205eMotusEMPNIA INC.IYE2026-09-21
00850065937212eMotusEMPNIA INC.IYE2026-09-21
00850065937229eMotusEMPNIA INC.IYE2026-09-21
00850065937236eMotusEMPNIA INC.IYE2026-09-21
00850065937243eMotusEMPNIA INC.IYE2026-09-21
00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21