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Opti-Handles

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
Opti-Handles FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Opti-Handles, 45cm (18") set of 2 FDA UDI
Model / Reference
RT-4458 FDA UDI
Description
Opti-Handles, 45cm (18") set of 2 FDA UDI

Identifiers

Catalog Number
RT-4458 FDA UDI
Primary DI / UDI-DI
00841962119917 FDA UDI
510(k) Number
K060671 FDA UDI
FDA Product Code
JAI FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5770 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indexed-immobilization patient positioning system

Opti-Handles by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Cleared under the same submission

K060671 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA UDI 392e6206-72af-43a2-b7a5-87c0cde0f19c 36 fields · synced Jun 1, 2026