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Ear, nose & throat mould without balloons, with two guide tubes, sterile

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
Ear, nose & throat mould without balloons, with two guide tubes, sterile FDA UDI
Generic Name
Nasopharynx brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
GM11003320 FDA UDI

Identifiers

Catalog Number
GM11003320 FDA UDI
Primary DI / UDI-DI
00816389022546 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Nasopharynx brachytherapy system applicator, remote-afterloading

Ear, nose & throat mould without balloons, with two guide tubes, sterile by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID

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 ac876382-d2b8-4676-9d90-ec012d552c51 34 fields · synced Jun 1, 2026