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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
Patient positioning foam mould kit FDA UDI
Device Name
Klarity Customized Head Mold 17x30cm AEP FDA UDI
Model / Reference
R550-CEAP2 FDA UDI
Description
Klarity Customized Head Mold 17x30cm AEP FDA UDI

Identifiers

Primary DI / UDI-DI
00817355027213 FDA UDI
510(k) Number
K132124 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Patient positioning foam mould kit 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 Conditional 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

K132124 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 36a16309-15cf-4cce-b773-46d218d8477a 35 fields · synced Jun 9, 2026