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Leipzig-style cone 30-45 mm diameter, with holder and guide

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
Leipzig-style cone 30-45 mm diameter, with holder and guide FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
GM11010170 FDA UDI

Identifiers

Catalog Number
GM11010170 FDA UDI
Primary DI / UDI-DI
00816389025202 FDA UDI
510(k) Number
K123815 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5700 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

No

FDA UDI

Category: General-purpose brachytherapy system applicator, remote-afterloading

Leipzig-style cone 30-45 mm diameter, with holder and guide by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as General-purpose brachytherapy system applicator, remote-afterloading.

Cleared under the same submission

K123815 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Varian Medical Systems Deutschland GmbH

Sources (1)

  • FDA UDI 0d33e044-9b72-4287-8d51-ae829d07f29e 34 fields · synced May 30, 2026