Duns Number:008999906
Device Description: The GATOR is intended to be used with 12F to 24F introducer sheaths to maintain a hemostat The GATOR is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.
Catalog Number
-
Brand Name
Gator® clipseal plug
Version/Model Number
8280
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2018
Issuing Agency
In HIBCC
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
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
8140190c-55a4-45c4-80d3-b51d2a3056c1
Public Version Date
April 16, 2018
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
M20682801
Quantity per Package
10
Contains DI Package
M20682800
Package Discontinue Date
February 28, 2018
Package Status
Not 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |