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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
PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm FDA UDI
Model / Reference
R902-3A FDA UDI
Description
PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm FDA UDI

Identifiers

Primary DI / UDI-DI
00817355023758 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
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 thermoplastic mould material

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 thermoplastic mould material.

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 ed6f3c29-5451-4858-993a-b1e10de90e73 33 fields · synced Jun 9, 2026