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Leksell Gamma Knife Perfexion

FDA UDI

Class II (US FDA UDI)

by Elekta Solutions AB

Identity

Trade Name
Leksell Gamma Knife Perfexion FDA UDI
Generic Name
Teletherapy radionuclide system, conventional FDA UDI
Device Name
LEKSELL GAMMA KNIFE PERFEXION FDA UDI
Model / Reference
715000 FDA UDI
Description
LEKSELL GAMMA KNIFE PERFEXION FDA UDI

Identifiers

Primary DI / UDI-DI
07340048303019 FDA UDI
FDA Product Code
IWB FDA UDI
GMDN Term
Teletherapy radionuclide system, conventional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5750 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Teletherapy radionuclide system, conventional

Leksell Gamma Knife Perfexion by Elekta Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Teletherapy radionuclide system, conventional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elekta Solutions AB

Sources (1)

  • FDA UDI 33a92f02-652c-43b8-aa51-2339fd72d34a 34 fields · synced May 30, 2026