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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
Klarity Uno™ Prone Breast Elevation Set. Includes Prone Breast Upper and Lower Elevation Blocks FDA UDI
Model / Reference
R612-BE4-E FDA UDI
Description
Klarity Uno™ Prone Breast Elevation Set. Includes Prone Breast Upper and Lower Elevation Blocks FDA UDI

Identifiers

Primary DI / UDI-DI
00817355029521 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
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

Category: Indexed-immobilization patient positioning system

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

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Cleared under the same submission

K112460 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Klarity Medical Products, LLC

Sources (1)

  • FDA UDI cc21419c-ff08-4d84-8e8f-e813e81222c4 34 fields · synced Jun 9, 2026