FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00817355027206
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
RNB-C10
Device description
Klarity Bitelok® Kit. Includes: Bitelok® and QuickFit™ tool
Published
2022-12-20
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
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
00817355027206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355027206008173550272068173550272060817355027206

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., helmet, frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine typically during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

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
00840510401658KLARITY MEDICALR550-S32026-10-08
00840510401627KLARITY MEDICALR550-OA12026-10-05
00840510401634KLARITY MEDICALR550-OA22026-10-05
00840510401641KLARITY MEDICALRSX-PL062026-10-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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