← Back to catalogue

Device Bag for Optune

FDA UDI

Class III (US FDA UDI)

by Novocure Inc

Identity

Trade Name
Device Bag for Optune FDA UDI
Generic Name
Alternating electric field antimitotic cancer treatment system generator FDA UDI
Model / Reference
BAG9100 FDA UDI

Identifiers

Catalog Number
BAG9100US FDA UDI
Primary DI / UDI-DI
07290107982078 FDA UDI
PMA Number
P100034 FDA UDI
FDA Product Code
NZK FDA UDI
GMDN Term
Alternating electric field antimitotic cancer treatment system generator FDA UDI

Classification

Device Class
Class III 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

Yes

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

Yes

FDA UDI

Category: Alternating electric field antimitotic cancer treatment system generator

Device Bag for Optune by Novocure Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alternating electric field antimitotic cancer treatment system generator.

Cleared under the same submission

P100034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Novocure Inc

Sources (1)

  • FDA UDI b67e265e-03f0-4c63-99f1-78ff3c5ed58b 36 fields · synced Jun 6, 2026