Duns Number:960091929
Device Description: Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case
Catalog Number
20800
Brand Name
Vitale
Version/Model Number
20800
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
73c864c0-8983-4468-b1d3-93a77ee50e40
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
September 17, 2018
Package DI Number
00856276008055
Quantity per Package
5
Contains DI Package
00856276008048
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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 10 |