Duns Number:103169095
Device Description: Gemini Twin Cleaning Pads with enzymatic detergent - 2 Pairs of Pads per Pack
Catalog Number
-
Brand Name
Gemini Twin Cleaning Pads with enzymatic detergent
Version/Model Number
GP120Z
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNL
Product Code Name
Accessories, Cleaning Brushes, For Endoscope
Public Device Record Key
08d93809-1f3e-40ca-b19e-0a86f0a4e305
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10843356100713
Quantity per Package
120
Contains DI Package
00843356100716
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 146 |