DYONICS - RFB MTO L.S DYONICS 300XL HERMES - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: RFB MTO L.S DYONICS 300XL HERMES

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More Product Details

Catalog Number

7210045F

Brand Name

DYONICS

Version/Model Number

7210045F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2021

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)

-

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

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

cac47671-ed29-4810-8905-a1919813365b

Public Version Date

November 05, 2021

Public Version Number

3

DI Record Publish Date

April 12, 2016

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