Zyris, Isolite, i2
- Primary DI
- 00810032660277
- Brand
- Zyris, Isolite, i2
- Company
- ZYRIS, INC.
- Model
- EIL0201
- Catalog number
- EIL0201
- Device description
- System, Isolite
- Published
- 2019-09-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EAZ | LIGHT, OPERATING, DENTAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EAZ | Light, Operating, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810032660277 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810032660277 | 00810032660277 | 810032660277 | 0810032660277 |
GMDN Terms
| Term | Definition |
|---|
| Dental suction system | An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 068038277
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- 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 |
|---|
| 00810032661250 | Isolite Mouthpiece | AIL0250 | AIL0250 | 2024-05-02 |
| 10810032661233 | Hoopla Retractor | CIR0304 | CIR0304 | 2024-04-19 |
| 10810032661240 | Hoopla Retractor | CIR0308 | CIR0308 | 2024-04-19 |
| 00810032660703 | Isolite, i2 | PIL0204 | PIL0204 | 2024-04-19 |
| 00810032660710 | Isolite, i2 | PIL0205 | PIL0205 | 2024-04-19 |
| 00810032660734 | Isolite, i2 | PIL0207 | PIL0207 | 2024-04-19 |
| 00810032660758 | Isolite, i2 | PIL0213 | PIL0213 | 2024-04-19 |
| 00810032660765 | Isolite, i3 | PIL0301 | PIL0301 | 2024-04-19 |
| 00810032660772 | Isolite, i3 | PIL0302 | PIL0302 | 2024-04-19 |
| 00810032660789 | Isolite, i3 | PIL0304 | PIL0304 | 2024-04-19 |
| 00810032660796 | Isolite, i3 | PIL0305 | PIL0305 | 2024-04-19 |
| 00810032660802 | Isolite, i3 | PIL0306 | PIL0306 | 2024-04-19 |
| 00810032660819 | Isolite, i3 | PIL0307 | PIL0307 | 2024-04-19 |
| 00810032660826 | Isolite, i3 | PIL0308 | PIL0308 | 2024-04-19 |
| 00810032660833 | Isolite, i3 | PIL0309 | PIL0309 | 2024-04-19 |
| 00810032660840 | Isolite, i3 | PIL0311 | PIL0311 | 2024-04-19 |
| 00810032660857 | Isolite, i3 | PIL0312 | PIL0312 | 2024-04-19 |
| 00810032660864 | Isolite, i3 | PIL0313 | PIL0313 | 2024-04-19 |
| 00810032660871 | Isolite, i3 | PIL0314 | PIL0314 | 2024-04-19 |
| 00810032660888 | Isolite, i3 | PIL0315 | PIL0315 | 2024-04-19 |
Other Devices Sharing Product Codes
zyris.com