Duns Number:868205779
Device Description: The Quick Connect for Pentax and SMART Medical Systems Ltd. GI Endoscopes is used with C1 The Quick Connect for Pentax and SMART Medical Systems Ltd. GI Endoscopes is used with C1160E Universal Flexible Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.
Catalog Number
QPC1724E
Brand Name
NA
Version/Model Number
Quick Connect
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
fa2e4555-f795-462e-80ab-67d2b6924f44
Public Version Date
October 25, 2022
Public Version Number
15
DI Record Publish Date
September 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |