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Elekta Unity

FDA UDI

Class II (US FDA UDI)

by Elekta Inc.

Identity

Trade Name
Elekta Unity FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
CT OVERLAY FDA UDI
Model / Reference
1061744 FDA UDI
Description
CT OVERLAY FDA UDI

Identifiers

Primary DI / UDI-DI
05060191071468 FDA UDI
FDA Product Code
KXJ FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1980 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Indexed-immobilization patient positioning system

Elekta Unity by Elekta Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elekta Inc.

Sources (1)

  • FDA UDI fe6de974-88f5-4a4c-948b-2a988dc0a880 34 fields · synced May 30, 2026