FDA UDI
In Commercial Distribution
🇺🇸 United States
Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
DI: 07290019505006
·
Model: 1
·
ZSQUARE LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE
- Primary DI
- 07290019505006
- Version / Model
- 1
- Catalog Number
- 200000
- Company Name
- ZSQUARE LTD
- Labeler DUNS
- 600333837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-07
- Public Version
- 2
- Public Version Date
- 2023-03-03
- Public Version Status
- Update
- Public Device Record Key
- 1c1aebcc-ab88-4171-a0ea-5a409d646b4d
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.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 63330 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07290019505013 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 07290019505006 | GS1 | ||||
| Package | 07290019505020 | GS1 | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +97236987600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220004 | 000 |