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VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source FDA UDI
Generic Name
Remote-afterloading brachytherapy source FDA UDI
Model / Reference
AL09400000 FDA UDI

Identifiers

Catalog Number
AL09400000 FDA UDI
Primary DI / UDI-DI
00816389028869 FDA UDI
510(k) Number
K122236 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
Remote-afterloading brachytherapy source 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Remote-afterloading brachytherapy source

VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K122236 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 a3a5da28-baa6-4d8a-bd24-5f639f62ac2e 34 fields · synced Jun 1, 2026