Pen, Marking, Surgical
The surgical marking pen is a hand-held instrument used to make temporary skin or tissue markings to guide incision placement or anatomical orientation during ophthalmic or other surgical procedures. It is classified as an FDA Class 1 device under 21 CFR 886.4570, indicating it poses the lowest level of risk and is subject only to general controls such as registration and labeling requirements. Product code HRP falls under the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HRP
- Device Class
- FDA class 1
- Regulation Number
- 886.4570
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.