Home GUDID 00840510400392 KLARITY MEDICAL
Primary DI 00840510400392
Brand KLARITY MEDICAL
Company Klarity Medical Products, LLC
Model R550-LB4
Device description Klarity Cushion™ customizable mold 15cm x 7 cm, 18mm thickness
Published 2025-10-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name IYE Accelerator, Linear, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYE Accelerator, Linear, Medical Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840510400392 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840510400392 00840510400392 840510400392 0840510400392
GMDN Terms# Term, Definition table Term Definition Patient positioning foam mould kit A collection of devices designed to facilitate the delivery of a self-hardening foam that is either poured or injected into a bag or container placed around a patient. After hardening, the foam and the bag/container form a patient-specific (custom-made) mould of that anatomy. The mould can be whole body or only selected body parts and are commonly used to help ensure adequate positioning and immobilization of the patient during radiation therapy treatments and to facilitate reproducible positioning for serial treatments.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840277411815 Gold Marker RIVERPOINT MEDICAL, LLC IYE 2026-03-11 00850002461343 BiomarC® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850002461350 Carbon Bright ® Carbon Medical Technologies, Inc. IYE 2024-07-23 00850016008176 VeraForm Viscus Biologics LLC IYE 2024-01-16 07340145700421 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700445 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700506 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700582 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700643 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145700667 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701060 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701084 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701107 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701121 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701145 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701169 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701183 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701206 Gold Anchor Naslund Medical AB IYE 2023-01-23 07340145701220 Gold Anchor Naslund Medical AB IYE 2023-01-23 B887001062 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B887001067 X-MARK Ultra Izi Medical Products, LLC IYE 2022-07-18 B8870010010 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010020 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010030 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010070 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010080 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010090 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010210 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010220 X-MARK Izi Medical Products, LLC IYE 2022-06-17 B8870010230 X-MARK Izi Medical Products, LLC IYE 2022-06-17