FDA.reportPublic FDA data

KLARITY MEDICAL

Primary DI
00817355023123
Brand
KLARITY MEDICAL
Company
KLARITY MEDICAL PRODUCTS, LLC
Model
RNE-102PL
Device description
Press-Lock Plastic Indexing Bar for Exact™ Couch Top 6 mm thickness MR Safe
Published
2018-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817355023123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355023123008173550231238173550231230817355023123

GMDN Terms#

Term, Definition table
TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034824691
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00840510401108KLARITY MEDICALR7512-70C2026-03-23
00840510401115KLARITY MEDICALR7512-50C2026-03-23
00840510401122KLARITY MEDICALR7512-35C2026-03-23
00840510401139KLARITY MEDICALR7512-47C2026-03-23
00817355025394KLARITY MEDICALR421U2025-10-30
00840510400088KLARITY MEDICALR625-NFCF92026-03-17
00840510401085KLARITY MEDICALKRA3-471122026-03-16
00840510401092KLARITY MEDICALKRA3-36462026-03-16
00817355028111KLARITY MEDICALRE-630ESCF2026-03-13
00817355025806KLARITY MEDICALPS-2022A2026-03-12
00817355025820KLARITY MEDICALPS-3200A2026-03-12
00817355025868KLARITY MEDICALPS-3201A2026-03-12
00817355026247KLARITY MEDICALPS-2400A2026-03-12
00840510401054KLARITY MEDICALGR7504-A30C2026-03-12
00840510401061KLARITY MEDICALRG-BHS-A2436F2026-03-12
00840510401078KLARITY MEDICALRG-BHS-8A24362026-03-12
00817355025622KLARITY MEDICALRE-7EC2022-01-05
00817355021976KLARITY MEDICALP-3201A2026-03-06
00817355025790KLARITY MEDICALPB-2412A2026-03-06
00817355025813KLARITY MEDICALP-3205A2026-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120562FibreplastQfixIYE2026-05-26
00840510401108KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401115KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401122KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510401139KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-23
00840510400088KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-17
00840510401085KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-16
00840510401092KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-16
00817355028111KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-13
00850072631035ChartCheckRadformation, IncIYE2026-03-13
00850072631059ChartCheckRadformation, IncIYE2026-03-13
00860001672770ClearCheck V2Radformation, IncIYE2026-03-13
00860001672794EZFluenceRadformation, IncIYE2026-03-13
00840510401054KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401061KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401078KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
10840277411812Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00840510401030KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-06
00840510401047KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-06
00817355029149KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-04
00840510401016KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-02
00817355027855KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-27
00817355028265KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-27
00817355024120KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355028968KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355029040KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-23
00817355024878KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355025363KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355025431KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18
00817355026971KLARITY MEDICALKlarity Medical Products, LLCIYE2026-02-18