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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
Vacuum-mould patient positioning system FDA UDI
Device Name
CUSTOM KLARITY TABLE PAD 1“ REGULAR FOAM - ROYAL BLUE VINYL COVER 52cm x 66cm (20.5” x 26“ x 1” thickness) Velcro closure on both ends FDA UDI
Model / Reference
KRA1-5266 FDA UDI
Description
CUSTOM KLARITY TABLE PAD 1“ REGULAR FOAM - ROYAL BLUE VINYL COVER 52cm x 66cm (20.5” x 26“ x 1” thickness) Velcro closure on both ends FDA UDI

Identifiers

Primary DI / UDI-DI
00817355027367 FDA UDI
510(k) Number
K112460 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Vacuum-mould patient positioning system 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vacuum-mould patient positioning system

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

Similar devices

Also classified as Vacuum-mould patient positioning system.

Cleared under the same submission

K112460 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 636ea804-3127-4645-9800-2db6721edc6e 34 fields · synced Jun 9, 2026