NA - The Quick Connect for Fujifilm GI Endoscopes is - STERIS CORPORATION

Duns Number:868205779

Device Description: The Quick Connect for Fujifilm GI Endoscopes is used with the C1160E Universal Flexible En The Quick Connect for Fujifilm GI Endoscopes is used with the C1160E Universal Flexible Endoscope Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Processing Systems.

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More Product Details

Catalog Number

QFC1777E

Brand Name

NA

Version/Model Number

Quick Connect

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

K090036,K101409,K102462,K113520,K131078,K161683,K170956,K173256,K180342,K182827,K190104,K191343,K192929,K210737,K211607,K222615

Product Code Details

Product Code

MED

Product Code Name

Sterilant, medical devices

Device Record Status

Public Device Record Key

63d70e35-269c-4b14-b05d-bf2b1ef49546

Public Version Date

October 25, 2022

Public Version Number

2

DI Record Publish Date

September 29, 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