Die, Wire Bending, Ent, Sterile
Die, Wire Bending, ENT, Sterile is a sterile surgical accessory used during ENT procedures to shape or bend wire prostheses to the required geometry before their placement in the middle ear during ossicular chain reconstruction. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JXW, regulated under 21 CFR 874.3540, and falls within the Ear, Nose, Throat medical specialty.
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Basic Information
- Product Code
- JXW
- Device Class
- FDA class 1
- Regulation Number
- 874.3540
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.