Zsquare ENT-Flex Console
- Primary DI
- 07290019505044
- Brand
- Zsquare ENT-Flex Console
- Company
- ZSQUARE LTD
- Model
- 1
- Catalog number
- 100000US
- Device description
- square ENT-Flex Console. Reusable. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Imaging Core. Contains illumination source, cart, foot switch, keyboard, monitor and CCU with accompanying software. Enables live imaging, snapshot and video recording.
- Published
- 2023-03-23
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K220004 | 000 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022-06-14 | EOB |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290019505044 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290019505044 | 07290019505044 | 7290019505044 |
GMDN Terms
| Term | Definition |
|---|
| Endoscopic video image processing/light source system | A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope. |
Contacts
| Phone | Email |
|---|
| +97236987600 | service@zsquaremedical.com |
Regulatory Flags
- DUNS number
- 600333837
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 07290019505037 | Zsquare ENT-Flex Imaging Core | 1 | 301001 | 2023-03-23 |
| 07290019505013 | Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE | 1 | 200000 | 2023-02-07 |
Other Devices Sharing Product Codes
zsquaremedical.com