FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00817355028401
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
RKB-3003
Device description
Klarity Bolus™ 30cm x 30cm, 3mm
Published
2025-11-20
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
K202747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202747000Klarity BolusKlarity Medical & Equipment (GZ) Co., Ltd.2021-05-14IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817355028401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355028401008173550284018173550284010817355028401

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
00817355027046KLARITY MEDICALRE-6342026-11-04
00840510401696KLARITY MEDICALR624-SCF1-7MR-12026-11-04
00817355028524KLARITY MEDICALR624-SCF1-5B2026-02-12
00817355027398KLARITY MEDICALR634-LE2025-08-26
00817355028654KLARITY MEDICALR616-AIR2025-05-14
00817355024694KLARITY MEDICALR624-SCF1-5N2020-06-01
00817355023536KLARITY MEDICALR624-SCF1-52018-04-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355027046KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00840510401696KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00841439120590TotalRTQfixIYE2026-11-04
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