Handpiece (Brace), Drill
The Drill Handpiece (Brace) is a manual, non-powered handpiece used to hold and guide neurosurgical drill bits during cranial procedures where precise, low-speed bone penetration is required without the use of a power source. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HBD under regulation 21 CFR 882.4325 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HBD
- Device Class
- FDA class 1
- Regulation Number
- 882.4325
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.