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Surface cone inset, 30 diameter x 20 mm, oval

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
Surface cone inset, 30 diameter x 20 mm, oval FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
GM11003640 FDA UDI

Identifiers

Catalog Number
GM11003640 FDA UDI
Primary DI / UDI-DI
00816389022799 FDA UDI
510(k) Number
K162018 FDA UDI
K983436 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

Dimensions & Sizes

Size
Lumen/Inner Diameter — 30 Millimeter FDA UDI

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

A comprehensive Surface Cone Inset device used in brachytherapy for temporary placement of radioactive sources in various anatomical regions. It includes a variety of applicators and their associated components, allowing for precise placement and removal. The device is designed for single or multiple source applications and features a remote-afterloading mechanism.

Similar devices

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

Cleared under the same submission

K162018 also covers:

K983436 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 560ca7fb-02ad-4d5e-9025-d06e14292768 35 fields · synced Jul 14, 2026