FDA.report

KLARITY MEDICAL

Primary DI
00817355024809
Brand
KLARITY MEDICAL
Company
KLARITY MEDICAL PRODUCTS, LLC
Model
R-120HF
Device description
PelvicFix™ Mask insert for reusable frame solid 1.6mm, 46x56cm
Published
2020-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817355024809PrimaryGS10

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

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00840510401108KLARITY MEDICALR7512-70C2026-03-23
00840510401115KLARITY MEDICALR7512-50C2026-03-23
00840510401122KLARITY MEDICALR7512-35C2026-03-23
00840510401139KLARITY MEDICALR7512-47C2026-03-23
00817355025394KLARITY MEDICALR421U2025-10-30
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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

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Primary DIBrandCompanyProduct codePublished
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
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00840510401061KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
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