← Back to catalogue

Klarity Medical

FDA UDI

Class II (US FDA UDI)

by Klarity Medical Products, LLC

Identity

Trade Name
Klarity Medical FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Indexing Bar for Elekta & Tomo FDA UDI
Model / Reference
RE-630E FDA UDI
Description
Indexing Bar for Elekta & Tomo FDA UDI

Identifiers

Primary DI / UDI-DI
00817355022287 FDA UDI
510(k) Number
K112460 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Klarity Medical by Klarity Medical Products, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112460 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Klarity Medical Products, LLC

Sources (1)

  • FDA UDI 68d5264e-0d8b-482b-91dc-e43914cc9865 36 fields · synced Jun 9, 2026