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: Klarity BiteLok™: complete package with BiteLok™, lower density dental putty, QuickFit™ tool, and tongue placement devices FDA UDI
Model / Reference: RNB-100L FDA UDI
Description: Klarity BiteLok™: complete package with BiteLok™, lower density dental putty, QuickFit™ tool, and tongue placement devices FDA UDI

Identifiers

Primary DI / UDI-DI: 00817355023871 FDA UDI
FDA Product Code: ELW FDA UDI
IYE FDA UDI
GMDN Term: Head/neck procedure positioner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 FDA UDI
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

Similar devices

Also classified as Head/neck procedure positioner.

ASSY, SCAN BOARD, HILL-ROM PROGRESSA — Neurologica Corporation · Class II
Orfit Industries — Orfit Industries NV · Class II
OPTION, EXTENDED SCANBOARD LONG POST WITH TARGET — Neurologica Corporation · Class II
Orfit Industries — Orfit Industries NV · Class II
AADCO — AADCO MEDICAL, INC. · Class I
AADCO — AADCO MEDICAL, INC. · Class I
Orfit Industries — Orfit Industries NV · Class II
Levo Prone Package Refurbished — Mizuho Orthopedic Systems, Inc. · Class I

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

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

Manufacturer

Manufacturer: Klarity Medical Products, LLC

Sources (1)

FDA UDI 373e92b1-ef09-486b-b0f5-ac3e17e5e212 33 fields · synced Jun 9, 2026