Duns Number:184805166
Device Description: ProCol Biologic Vascular Graft, 6mm x 10 cm
Catalog Number
HJL016-10-N
Brand Name
ProCol Biologic Vascular Graft
Version/Model Number
HJL016-10-N
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
P020049
Product Code
LXA
Product Code Name
Tissue Graft Of 6mm And Greater
Public Device Record Key
05f6531b-7ed2-4125-af0f-c1ca92c72c4e
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
March 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |
| 3 | A medical device with high risk that requires premarket approval | 22 |