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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 thermoplastic mould material FDA UDI
Device Name
Klarity Blue S-type Open Larynx Head & Shoulder Mask with 3.2mm FDA UDI
Model / Reference
RB461-3210STF1 FDA UDI
Description
Klarity Blue S-type Open Larynx Head & Shoulder Mask with 3.2mm FDA UDI

Identifiers

Primary DI / UDI-DI
00081735502748 FDA UDI
510(k) Number
K022708 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Patient positioning thermoplastic mould material 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

K022708 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 0f4c4e09-02ce-4258-aeb1-8dd33d5beb78 35 fields · synced Jun 9, 2026