Primary Device ID | D841092164001 |
NIH Device Record Key | 4f7bb8aa-2205-4f9b-83a7-bd5e8eab031c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Norris Extra Broad Archwire |
Version Model Number | 1 |
Company DUNS | 006335558 |
Company Name | Ortho Solutions, LC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D841092164001 [Primary] |
DZC | Wire, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-07 |
Device Publish Date | 2025-06-27 |
D84109619251 | 1 |
D84109519251001 | 1 |
D84109518181001 | 1 |
D84109514251001 | 1 |
D8410950141001 | 1 |
D841095001001 | 1 |
D841094267001 | 1 |
D841093265001 | 1 |
D841092268001 | 1 |
D841092265501 | 1 |
D841092265001 | 1 |
D841092263501 | 1 |
D841092262001 | NiTi .016 x .016 square archwire |
D841092261001 | NiTi .014 x .025 rectangular archwire |
D841092164001 | NiTi .018 round archwire |
D841093267001 | 1 |
D841092266001 | 1 |
D841092263001 | NiTi rectangular archwire |
D841092163001 | NiTi, round .016 archwire |
D841092162001 | NiTi round .014 archwire |