Primary Device ID | D798WING0 |
NIH Device Record Key | 336e40fe-5855-4fc5-9bae-f76a29fa7759 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Syringe Assist |
Version Model Number | WING |
Company DUNS | 113170088 |
Company Name | RELIANCE ORTHODONTIC PRODUCTS INC |
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 | false |
Lot Batch | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D798WING0 [Primary] |
ECP | Instrument, Ligature Tucking, 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 | 2023-09-27 |
Device Publish Date | 2023-09-19 |
00840479203676 - LED ProSeal | 2025-08-13 LED ProSeal |
00840479203683 - LED ProSeal | 2025-08-13 LED ProSeal |
D7981PROSY0 - ProSeal | 2025-04-07 ProSeal |
D7981RWXSAM0 - ReliaWax | 2025-04-07 ReliaWax |
D798PROSY0 - ProSeal | 2025-04-07 ProSeal |
D798RWXSAM0 - ReliaWax | 2025-04-07 ReliaWax |
D7981TKOC150 - TKO Clear | 2024-08-09 |
D798TKOC150 - TKO Clear | 2024-08-09 |