Die, Wire Bending, Ent, Non-sterile

Device Code: 1625

Product Code(s): NNP

Definition: Prosthesis Modification Instrument For Ossicular Replacement Surgery; See Product Code JXW.

Device Classification Information

• Device Type ID: 1625
• Device Name: Die, Wire Bending, Ent, Non-sterile
• Regulation Description: Prosthesis Modification Instrument For Ossicular Replacement Surgery.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Ear, Nose, And Throat Devices Branch (ENTB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 874.3540 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NNP
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1625
• Device: Die, Wire Bending, Ent, Non-sterile
• Product Code: NNP
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Prosthesis Modification Instrument For Ossicular Replacement Surgery.
• CFR Regulation Number: 874.3540 [🔎]

Device Problems
Device Damaged By Another Device	1
Mechanical Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:56:45