Identity
- Trade Name
- VS3 Iridium FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View - Refurbished FDA UDI
- Model / Reference
- VS3-IR FDA UDI
- Description
- VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View - Refurbished FDA UDI
Identifiers
- Catalog Number
- 153-0053RFB FDA UDI
- Primary DI / UDI-DI
- 10813040013254 FDA UDI
- 510(k) Number
- K183453 FDA UDI
- FDA Product Code
- HRX FDA UDIGCJ FDA UDIOWN FDA UDIGWG FDA UDI
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI876.1500 FDA UDI882.1480 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
VS3 Iridium by Visionsense Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183453 also covers:
- Lamp Module For LS300 Xenon Lightsource — VISIONSENSE LTD.
- Power Cord for VS3 Cart - Argentina — VISIONSENSE LTD.
- Power Cord for VS3 Cart - Brazil — VISIONSENSE LTD.
- Power Cord for VS3 Cart - Italy — VISIONSENSE LTD.
- Power Cord for VS3 Cart - US — VISIONSENSE LTD.
- Twin gas bottle holder — VISIONSENSE LTD.
- VS3 Xenon light source (300W) - Refurbished — VISIONSENSE LTD.
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
- Visionsense Ltd.
Sources (1)
- FDA UDI de14260d-ada9-4c7a-b43d-498d56e90654 35 fields · synced Jun 1, 2026