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Nasopharynx Applicator Set

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
Nasopharynx Applicator Set FDA UDI
Generic Name
Nasopharynx brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
GM11004690 FDA UDI

Identifiers

Catalog Number
GM11004690 FDA UDI
Primary DI / UDI-DI
00816389023284 FDA UDI
510(k) Number
K042360 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
Nasopharynx 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

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

Category: Nasopharynx brachytherapy system applicator, remote-afterloading

Nasopharynx Applicator Set by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasopharynx brachytherapy system applicator, remote-afterloading.

Cleared under the same submission

K042360 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 f51f4ab7-eeae-457e-8abf-249526fe4562 34 fields · synced Jun 6, 2026