Primary Device ID | 00810152820797 |
NIH Device Record Key | a83814ad-bf74-4782-ba88-3dac83355113 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RANNIX |
Version Model Number | 901M-WH |
Company DUNS | 085719913 |
Company Name | Ortho Pro Dent LLC |
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 | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 941-402-6504 |
edward@orthoprodent.com | |
Phone | 941-402-6504 |
edward@orthoprodent.com | |
Phone | 941-402-6504 |
edward@orthoprodent.com | |
Phone | 941-402-6504 |
edward@orthoprodent.com | |
Phone | 941-402-6504 |
edward@orthoprodent.com | |
Phone | 941-402-6504 |
edward@orthoprodent.com | |
Phone | 941-402-6504 |
edward@orthoprodent.com |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810152820797 [Primary] |
NJM | Bracket, Ceramic, 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 | 2024-11-13 |
Device Publish Date | 2024-11-05 |
00810152820810 | Orthodontic Ceramic brackets with metal slot, Roth, slot .022" , Hooks on 3,4,5 |
00810152820803 | Orthodontic Ceramic brackets with metal slot, MBT, slot .022" , Hooks on 3,4,5 |
00810152820797 | Orthodontic Ceramic brackets with metal slot, MBT, slot .018" , Hooks on 3,4,5 |
00810152820780 | Orthodontic Ceramic brackets with metal slot, Roth, slot .018" , Hooks on 3,4,5 |