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Lens 4k

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
LENS 4K FDA UDI
Generic Name
Camera control unit FDA UDI
Device Name
KIT US LENS 4K CCU WIFI VERSION FDA UDI
Model / Reference
72205225 FDA UDI
Description
KIT US LENS 4K CCU WIFI VERSION FDA UDI

Identifiers

Catalog Number
72205225 FDA UDI
Primary DI / UDI-DI
00885556731130 FDA UDI
510(k) Number
K191177 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Camera control unit 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Camera control unit

Lens 4k by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Camera control unit.

Cleared under the same submission

K191177 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI f137b685-ccbb-4c3e-94cd-dfc376b3799b 36 fields · synced Jun 6, 2026