FDA.report

KLARITY MEDICAL

Primary DI
00817355025943
Brand
KLARITY MEDICAL
Company
Klarity Medical Products, LLC
Model
CB-3200A
Device description
Klarity Contour Blend Thermoplastic Sheet no perforation, 3.2mm, 610x460mm
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ILHSplint, Hand, And Components
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817355025943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355025943008173550259438173550259430817355025943

GMDN Terms

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

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 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 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
00810220800041Adler Instrument CompanyAdler, Inc.ILH2026-03-17
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
00817355025806KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025820KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355025868KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
00817355026247KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-12
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
00810178883943ViveVIVE HEALTH LLCILH2026-03-06
00817355021976KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025790KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025813KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025837KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025844KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025899KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06
00817355025912KLARITY MEDICALKlarity Medical Products, LLCILH2026-03-06