| Primary Device ID | 00862872000324 |
| NIH Device Record Key | c46e55aa-9d26-40a9-a617-29926d75d394 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonus M4 |
| Version Model Number | M 4 |
| Catalog Number | 133-1204 |
| Company DUNS | 002965168 |
| Company Name | ENGLER ENGINEERING CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Length | 1.9 Inch |
| Width | 0.25 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862872000324 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
[00862872000324]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-12 |
| Device Publish Date | 2021-05-04 |
| 00862872000300 - Sonus | 2021-05-12 Dental scaling tip - rounded point for Engler insert A47030 |
| 00862872000317 - Sonus | 2021-05-12 Dental scaling tip - fine point for use with the Engler A47030 Insert |
| 00862872000324 - Sonus M4 | 2021-05-12Dental scaling tip - broad spatula style to screw into Engler insert A47030 |
| 00862872000324 - Sonus M4 | 2021-05-12 Dental scaling tip - broad spatula style to screw into Engler insert A47030 |
| 00862872000331 - Sonus Stack (Insert) | 2021-05-12 Sonus 18K magnetostrictive insert with threads for interchangeable tips for the Sonus V dental device |
| 00862872000348 - Sonus Nose Cone | 2021-05-12 White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device) |
| 00862872000355 - SONUS V | 2021-05-12 Dental magnetostrictive scaler 18 K, with four (4) M series tips (2 - M1 and 2 M2 or M4) insert and nose cone. |
| 00862872000362 - Engler 25K Series | 2021-05-12 Dental 25K magnetostrictive insert with pointed tip |
| 00862872000379 - Engler 25K Series | 2021-05-12 Dental 25K magnetostrictive insert with broad spatula tip |