Product Code: RAG FDA not classified

Welder

Unknown

The welder classification (product code RAG) covers equipment using ultrasound to weld objects in commercial or industrial applications, with no medical purpose. These devices are not classified within the standard medical device framework and are GMP-exempt. No regulation number, medical specialty, or submission type is assigned.

510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active

Basic Information

Product Code
RAG
Device Class
FDA not classified
Medical Specialty
Unknown

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Equipment used to weld objects in commercial or industrial applications