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Rotterdam Nasopharyngeal Mold

FDA UDI

Class II (US FDA UDI)

by Nucletron B.V.

Identity

Trade Name
Rotterdam Nasopharyngeal Mold FDA UDI
Generic Name
Nasopharynx brachytherapy system applicator, remote-afterloading FDA UDI
Device Name
Nasopharynx Catheter set 1+2 FDA UDI
Model / Reference
089061-01 FDA UDI
Description
Nasopharynx Catheter set 1+2 FDA UDI

Identifiers

Primary DI / UDI-DI
08717213010093 FDA UDI
510(k) Number
K983337 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Nasopharynx brachytherapy system applicator, remote-afterloading

Rotterdam Nasopharyngeal Mold by Nucletron B.V. — 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

K983337 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nucletron B.V.

Sources (1)

  • FDA UDI bb96067d-c765-4e71-9f77-02914c5a8a0a 35 fields · synced May 30, 2026