RUSCH - RUSCH POLARIS FO BLADE PHILIPS 1 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: RUSCH POLARIS FO BLADE PHILIPS 1

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More Product Details

Catalog Number

4150011

Brand Name

RUSCH

Version/Model Number

IPN055753

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

59c6f0b0-18c6-4902-823d-c1f42ac5ca0b

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Additional Identifiers

Package DI Number

24026704734300

Quantity per Package

10

Contains DI Package

04026704734306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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