KLARITY MEDICAL

Primary DI
00817355027046
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
RE-634
Device description
Klarity Replacement Indexing Bar for R634-LCF Leg Positioner
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
K112460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112460000MULTIPLELarson Medical Products, Inc.2011-10-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817355027046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355027046008173550270468173550270460817355027046

Regulatory Flags#

DUNS number
034824691
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817355022201Klarity MedicalRLG-ESH3-2412CN2016-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850065937168eMotusEMPNIA INC.IYE2026-09-21