Duns Number:202659140
Device Description: The Pentax GI Endoscopes without Water Jet Drying Tube and Connector Set used with the Re The Pentax GI Endoscopes without Water Jet Drying Tube and Connector Set used with the Reliance 6000 Series Endoscope Drying and Storage Cabinet.
Catalog Number
RECT1CON1P
Brand Name
NA
Version/Model Number
Reliance 6000 Connectors
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
-
Product Code
JRJ
Product Code Name
UNIT, DRYING
Public Device Record Key
362bb7d7-59d7-4246-beac-036231e2a022
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
February 05, 2021
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |