Duns Number:960091929
Device Description: Vitale Collagen Powder, 1 gram/packet, 10 packets/box, 10 boxes/case, 8 cases/overpack
Catalog Number
22000
Brand Name
Vitale
Version/Model Number
22000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030921,K030921,K030921,K030921
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
976c75ad-b7a4-4deb-b7e8-a5bc3f24cb2e
Public Version Date
May 06, 2020
Public Version Number
3
DI Record Publish Date
May 24, 2019
Package DI Number
00850005565208
Quantity per Package
8
Contains DI Package
10850005565199
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
overpack
| 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 |