Duns Number:604056226
Device Description: Vascular Loops, Sterile, Blue, Super Maxi, 18" long, 2/pkg
Catalog Number
-
Brand Name
Key Surgical Vascular Loops
Version/Model Number
VL-214
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDC
Product Code Name
Instrument, Surgical, Disposable
Public Device Record Key
dabf5600-96c2-4c1a-81e8-069b137898bd
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2020
Package DI Number
10849771030918
Quantity per Package
10
Contains DI Package
00849771030911
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 | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |