Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
- Primary DI
- 07290019505013
- Brand
- Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
- Company
- ZSQUARE LTD
- Model
- 1
- Catalog number
- 200000
- Device description
- Zsquare ENT-Flex Single-Use Shell. A single-use flexilble rhinolaryngoscope sterile from package. To be used with Zsquare ENT-Flex Imaging Core and Zsquare ENT-Flex Console.
- Published
- 2023-02-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|
| 07290019505013 | Package | GS1 | 5 | In Commercial Distribution |
| 07290019505020 | Package | GS1 | 20 | In Commercial Distribution |
| 07290019505006 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290019505013 | 07290019505013 | 7290019505013 |
| 07290019505020 | 07290019505020 | 7290019505020 |
| 07290019505006 | 07290019505006 | 7290019505006 |
GMDN Terms
| Term | Definition |
|---|
| Flexible video otorhinolaryngoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device. |
Contacts
| Phone | Email |
|---|
| +97236987600 | service@zsquaremedical.com |
Regulatory Flags
- DUNS number
- 600333837
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- 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
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 07290019505037 | Zsquare ENT-Flex Imaging Core | 1 | 301001 | 2023-03-23 |
| 07290019505044 | Zsquare ENT-Flex Console | 1 | 100000US | 2023-03-23 |
Other Devices Sharing Product Codes
zsquaremedical.com