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Leak stop channel marker set, 13-24

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
Leak stop channel marker set, 13-24 FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
GM11010520 FDA UDI

Identifiers

Primary DI / UDI-DI
00816389025400 FDA UDI
510(k) Number
K152018 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Leak stop channel marker set, 13-24 by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K152018 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 4a745808-f456-45e4-ba87-87ccca3a9f22 34 fields · synced May 30, 2026