Catalog Number
HP0510E
Brand Name
Veriset
Version/Model Number
HP0510E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2016
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
-
Product Code
LMG
Product Code Name
Agent, Absorbable Hemostatic, Non-Collagen Based
Public Device Record Key
6dfe4404-acba-4d46-87ad-e46dc3094987
Public Version Date
August 09, 2019
Public Version Number
6
DI Record Publish Date
April 15, 2016
Package DI Number
10884521082557
Quantity per Package
6
Contains DI Package
20884521082554
Package Discontinue Date
April 15, 2016
Package Status
Not in Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 132 |
2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
3 | A medical device with high risk that requires premarket approval | 202 |
U | Unclassified | 40 |