Duns Number:243880700
Device Description: Bedside Enzymatic Sponge Kits, Dry Tubular Sponge in a large freestanding pouch to use as Bedside Enzymatic Sponge Kits, Dry Tubular Sponge in a large freestanding pouch to use as a basin and simply add 500mL of water
Catalog Number
17-122
Brand Name
Batrik Your First PrAmLi Power Enzyme
Version/Model Number
17-122
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"
Yes
For Single-Use
-
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
c4a28aac-925a-4829-8275-7c277063893d
Public Version Date
January 28, 2022
Public Version Number
2
DI Record Publish Date
September 25, 2020
Package DI Number
00690521015067
Quantity per Package
15
Contains DI Package
00690521015005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |