Duns Number:960091929
Device Description: Calcium Alginate Ropes, 5/box, 10 boxes/case
Catalog Number
20650
Brand Name
Vitale STRONG
Version/Model Number
20650
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
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
4bdc3e9f-8611-4fe4-a047-3da63c1f2ea8
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
May 27, 2020
Package DI Number
00850005565475
Quantity per Package
5
Contains DI Package
00850005565468
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 |