N/A - SVCE FP LCD 26 NDS HD RADIANCE - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: SVCE FP LCD 26 NDS HD RADIANCE

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More Product Details

Catalog Number

72202591S

Brand Name

N/A

Version/Model Number

72202591S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KQM

Product Code Name

CAMERA, SURGICAL AND ACCESSORIES

Device Record Status

Public Device Record Key

0e07f16d-d904-4e52-b12f-e54bbddcb112

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351