Duns Number:103169095
Device Description: First Step Bedside Kit - Flat Pouch, Krinkle Cleaning Pad - 1 Pouch
Catalog Number
-
Brand Name
First Step Bedside Kit - Flat Pouch, Krinkle Cleaning Pad
Version/Model Number
EP-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 2022
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
1c2bb48a-0df6-41f9-944b-63eccfc1d59a
Public Version Date
February 07, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2020
Package DI Number
10843356100249
Quantity per Package
30
Contains DI Package
00843356100242
Package Discontinue Date
February 04, 2022
Package Status
Not 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 |