NA - The Frazier Suction Tube provides manual cleaning - STERIS CORPORATION

Duns Number:868205779

Device Description: The Frazier Suction Tube provides manual cleaning results for surgical instruments.

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More Product Details

Catalog Number

PK45908

Brand Name

NA

Version/Model Number

Channel

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MNL

Product Code Name

ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Device Record Status

Public Device Record Key

bf635959-8c40-4047-9289-9b266b3bce63

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557