Primary Device ID | D798PASACC0 |
NIH Device Record Key | 4031b299-2c51-4285-a4e7-f637779a86c3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Accessory Pack |
Version Model Number | PASACC |
Catalog Number | PASACC |
Company DUNS | 113170088 |
Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
Device Count | 1 |
DM Exempt | true |
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 | false |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | 6307734009 |
paulgropi@aol.com | |
Phone | 6307734009 |
paulgropi@aol.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D798PASACC0 [Primary] |
ECP | Instrument, Ligature Tucking, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2016-09-20 |
D7981TKOC150 - TKO Clear | 2024-08-09 |
D798TKOC150 - TKO Clear | 2024-08-09 |
D79821BTIPS101 - Brush Tips | 2023-12-21 |
D798RBTA0 - Tweezers | 2023-12-21 |
D798RBTP0 - Tweezers | 2023-12-21 |
D798RBX0 - ReliaBox | 2023-12-21 ReliaBox |
D798RBXK0 - ReliaBox | 2023-12-21 ReliaBox Kit |
D7981BEGSSAM0 - Gel Etchant | 2023-09-27 |