Duns Number:828222781
Device Description: The Reliance DG Dry Germicide is a single-use dry germicide used only in the Reliance EPS The Reliance DG Dry Germicide is a single-use dry germicide used only in the Reliance EPS Endoscope Processing System. The net contents are 272g per cup.
Catalog Number
D5100
Brand Name
Reliance
Version/Model Number
D5100
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
Yes
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
NZA
Product Code Name
Accessories, germicide, cleaning, for endoscopes
Public Device Record Key
46f3e0c1-5749-4e15-bfdd-a3c7335a9b9e
Public Version Date
April 19, 2022
Public Version Number
12
DI Record Publish Date
September 08, 2016
Package DI Number
50724995083774
Quantity per Package
4
Contains DI Package
10724995083776
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |