Identity
- Trade Name
- Zsquare ENT-Flex Imaging Core FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Zsquare ENT-Flex Imaging Core. Reusable. Hand Held. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Console. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Zsquare ENT-Flex Imaging Core. Reusable. Hand Held. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Console. FDA UDI
Identifiers
- Catalog Number
- 301001 FDA UDI
- Primary DI / UDI-DI
- 07290019505037 FDA UDI
- 510(k) Number
- K220004 FDA UDI
- FDA Product Code
- OEB FDA UDI
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope video camera
Zsquare ENT-Flex Imaging Core by Zsquare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220004 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zsquare Ltd
Sources (1)
- FDA UDI a067ac8b-bee2-402a-b70d-c5e13848fc8a 36 fields · synced May 31, 2026