Model: TOPA12
DI: 08800184900019
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2da6740b-2a8f-4868-81a6-09242c7f6411
Distribution Status:
In Commercial Distribution
DUNS Number:
695621620
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800184900019
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37606
Name: Diagnostic x-ray system generator, portable
Definition:
An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.
FDA Product Codes
IZL
System, X-Ray, Mobile