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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
AEP Custom Klarity Cushion™ for Head Support, 20x30cm FDA UDI
Model / Reference
R550-CAEP1 FDA UDI
Description
AEP Custom Klarity Cushion™ for Head Support, 20x30cm FDA UDI

Identifiers

Primary DI / UDI-DI
00817355023840 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

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: Patient positioning foam mould kit

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

Similar devices

Also classified as Patient positioning foam mould kit.

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 d1f488b2-3db5-47fe-9bc8-5b41a4b0cf0b 33 fields · synced Jun 9, 2026