RUSCH - RUSCH GREENLITE SU MTL BLADE MAC 2 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: RUSCH GREENLITE SU MTL BLADE MAC 2

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More Product Details

Catalog Number

004551002

Brand Name

RUSCH

Version/Model Number

IPN048385

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

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

CCW

Product Code Name

LARYNGOSCOPE, RIGID

Device Record Status

Public Device Record Key

ad5ec434-6bce-4ac3-b5c6-543d5bddb097

Public Version Date

January 08, 2020

Public Version Number

3

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

34026732626063

Quantity per Package

20

Contains DI Package

14026731626060

Package Discontinue Date

February 21, 2019

Package Status

Not in Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26