Device
Klarity Cushion™ customizable mold 44cm x 64cm, 37mm thickness
Manufacturer
Klarity Medical Products, LLC
Klarity Medical Products, LLC
Model: R550-HS3
DI: 00840510401191
Status: New
MRI: MR Safe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Klarity Cushion™ customizable mold 44cm x 64cm, 37mm thickness
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1d0a2f56-bd99-45f2-a53e-964c53119502
Distribution Status:
In Commercial Distribution
DUNS Number:
034824691
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840510401191
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40894
Name: Patient positioning foam mould kit
Definition:
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.
FDA Product Codes
IYE
Accelerator, Linear, Medical
Premarket Submissions
Submission Number:
K132124
Supplement Number:
000