Identity
- Trade Name
- LENS FDA UDI
- Generic Name
- Endoscopic video imaging system FDA UDI
- Device Name
- LENS INTEGRATED SYSTEM NON-WIFI VERSION FDA UDI
- Model / Reference
- 72204685 FDA UDI
- Description
- LENS INTEGRATED SYSTEM NON-WIFI VERSION FDA UDI
Identifiers
- Catalog Number
- 72204685 FDA UDI
- Primary DI / UDI-DI
- 00885556617908 FDA UDI
- 510(k) Number
- K153606 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic video imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Category: Endoscopic video imaging system
Lens by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic video imaging system.
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- NeedleView 0 Degree 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC · Class II
- NeedleView 10 Degree 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC · Class II
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- 1.2mm InnerVue II Scope Kit — BIOVISION TECHNOLOGIES, LLC · Class II
Cleared under the same submission
K153606 also covers:
- KIT, US LENS Integrated System — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
- LENS — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI dccb25f6-d276-4473-bad0-325b94ff8412 36 fields · synced Jun 8, 2026