Punch, Skull
The Skull Punch is a manual neurosurgical instrument used to create perforations or openings in the skull during cranial surgical procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only, reflecting its straightforward mechanical nature. The product code is GXJ under regulation 21 CFR 882.4750 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- GXJ
- Device Class
- FDA class 1
- Regulation Number
- 882.4750
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.