Device
Klarity White™ Thermoplastic Sheet 15cm x 15cm, solid, 1.6mm
Manufacturer
Klarity Medical Products, LLC
Klarity Medical Products, LLC
Model: R-1600E
DI: 00840510401245
Status: New
MRI: MR Safe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Klarity White™ Thermoplastic Sheet 15cm x 15cm, solid, 1.6mm
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a35a3c4f-ff9b-4926-8408-78ddd7493109
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:
00840510401245
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40896
Name: Patient positioning thermoplastic mould material
Definition:
A 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).
FDA Product Codes
ILH
Splint, Hand, And Components