510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NNHClass II

Needle, Conduction, Anesthesia, Reprocessed

21 CFR 868.5150 / Anesthesiology
FDA source (opens on fda.gov)

NNH is the FDA product code for Needle, Conduction, Anesthesia, Reprocessed, a class II device type, regulated under 21 CFR 868.5150. FDA's definition for this code reads: "A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NNH
Device name
Needle, Conduction, Anesthesia, Reprocessed
FDA definition
A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NNH.