510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NNTClass I

Punch, Gelfoam, Non-Sterile

21 CFR 874.3540 / Ear, Nose, Throat
FDA source (opens on fda.gov)

NNT is the FDA product code for Punch, Gelfoam, Non-Sterile, a class I device type, regulated under 21 CFR 874.3540. FDA's definition for this code reads: "Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NNT
Device name
Punch, Gelfoam, Non-Sterile
FDA definition
Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ
Regulation
21 CFR 874.3540
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code