FDA UDI
In Commercial Distribution
🇺🇸 United States
Zsquare ENT-Flex Console
DI: 07290019505044
·
Model: 1
·
ZSQUARE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zsquare ENT-Flex Console
- Primary DI
- 07290019505044
- Version / Model
- 1
- Catalog Number
- 100000US
- Company Name
- ZSQUARE LTD
- Labeler DUNS
- 600333837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-23
- Public Version
- 1
- Public Version Date
- 2023-03-31
- Public Version Status
- New
- Public Device Record Key
- 07b16803-440b-48d8-a451-94453f9c6570
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34540 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019505044 | GS1 |
Customer Contacts
- Phone
- +97236987600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220004 | 000 |