Primary Device ID | D798SP1 |
NIH Device Record Key | 11582721-8f86-4e5f-9b53-dc4ef8ad84df |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | sponge pellets |
Version Model Number | SP |
Catalog Number | SP |
Company DUNS | 113170088 |
Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
Device Count | 500 |
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 | false |
OTC Over-The-Counter | false |
Phone | 6307734009 |
paulgropi@aol.com | |
Phone | 6307734009 |
paulgropi@aol.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D798SP0 [Unit of Use] |
HIBCC | D798SP1 [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 | 2016-09-04 |
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 |