NA - The Pentax Bronchoscopes, Cystoscopes, Intubation - Corporation Steris Canada

Duns Number:202659140

Device Description: The Pentax Bronchoscopes, Cystoscopes, Intubation scopes, Nasopharyngoscopes and Ureterosc The Pentax Bronchoscopes, Cystoscopes, Intubation scopes, Nasopharyngoscopes and Ureteroscopes Drying Tube and Connector Set is used with the Reliance 6000 Series Endoscope Storage and Drying Cabinet.

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More Product Details

Catalog Number

RECT1CON3P

Brand Name

NA

Version/Model Number

Reliance 6000 Connectors

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"

-

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

JRJ

Product Code Name

UNIT, DRYING

Device Record Status

Public Device Record Key

f790811f-417c-4233-a80f-3194b92ffe40

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

February 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORPORATION STERIS CANADA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 262