Sonus M 3 Tip
- Primary DI
- 00636266958368
- Brand
- Sonus M 3 Tip
- Company
- ENGLER ENGINEERING CORPORATION
- Model
- M 3
- Catalog number
- 133-1203
- Device description
- Sonus Scaling Tip - Sickle
- Published
- 2018-07-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| ELC | Scaler, Ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00636266958368 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00636266958368 | 00636266958368 | 636266958368 | 0636266958368 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ultrasonic dental scaling/debridement system handpiece tip, periodontal | An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Liquid Chemical;Dry Heat Sterilization |
Regulatory Flags#
- DUNS number
- 002965168
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00862872000300 | Sonus | M 1 | 133-1201 | 2021-05-04 |
| 00862872000317 | Sonus | M 2 | 133-1202 | 2021-05-04 |
| 00862872000324 | Sonus M4 | M 4 | 133-1204 | 2021-05-04 |
| 00862872000331 | Sonus Stack (Insert) | A47030 | A47030 | 2021-05-04 |
| 00862872000348 | Sonus Nose Cone | 806-1105 | 806-1105 | 2021-05-04 |
| 00862872000355 | SONUS V | Sonus V | A52000 | 2021-05-04 |
| 00862872000362 | Engler 25K Series | S 1 | A70101 | 2021-05-04 |
| 00862872000379 | Engler 25K Series | S 4 | A70104 | 2021-05-04 |
| 00636266957262 | SONUS V SCALER | Sonus V | A52000 | 2018-07-16 |
| 00636266958351 | Sonus M 2 Tip | M 2 | 133-1202 | 2018-07-16 |
| 00636266958306 | Sonus Stack | A47030 | A47030 | 2018-07-09 |
| 00636266958337 | Sonus Nose Cone | 806-1105 | 806-1105 | 2018-07-09 |
| 00636266958344 | Sonus M 1 Tip | M 1 | 133-1201 | 2018-07-09 |
| 00636266958375 | Sonus M 4 Tip | M 4 | 133-1204 | 2018-07-09 |
| 00636266958702 | Engler 25K Series S-1 | S 1 | A70101 | 2018-07-09 |
| 00636266958719 | Engler 25K Series S-4 | S-4 | A70104 | 2018-07-09 |
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