Device
Klarity Table Top Pad 2.5cm x 52cm x 33cm, with binding closure
Manufacturer
Klarity Medical Products, LLC
Klarity Medical Products, LLC
Model: KRA3-5233
DI: 00840510401221
Status: New
MRI: MR Safe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Klarity Table Top Pad 2.5cm x 52cm x 33cm, with binding closure
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a4fd0e8f-5200-47da-9fd1-8bc7cafed1cb
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:
00840510401221
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40897
Name: Indexed-immobilization patient positioning system
Definition:
A assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.
FDA Product Codes
IYE
Accelerator, Linear, Medical
Premarket Submissions
Submission Number:
K112460
Supplement Number:
000