Klarity Medical

FDA UDI

Class II (US FDA UDI)

by Klarity Medical Products, LLC

Identity

Trade Name: KLARITY MEDICAL FDA UDI
Generic Name: Head/neck procedure positioner FDA UDI
Device Name: Tongue Placement Accessory Packet for Klarity Bitelok® Includes: Long and Short Tongue Depressors, Right and Left Tongue Diverters, IFU, and Removal Tool. FDA UDI
Model / Reference: RNB-11 FDA UDI
Description: Tongue Placement Accessory Packet for Klarity Bitelok® Includes: Long and Short Tongue Depressors, Right and Left Tongue Diverters, IFU, and Removal Tool. FDA UDI

Identifiers

Primary DI / UDI-DI: 00817355024106 FDA UDI
510(k) Number: K022708 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Head/neck procedure positioner 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Head/neck procedure positioner

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

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Klarity Medical Products, LLC

Sources (1)

FDA UDI e6275e77-8492-48b4-b71a-659ce8788516 34 fields · synced Jun 9, 2026