Duns Number:008999906
Device Description: The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and pla The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Catalog Number
-
Brand Name
GrebSet® micro-introducer kit
Version/Model Number
7950
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
44f59291-b45b-42b0-b6f7-f6a908846727
Public Version Date
November 11, 2019
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
M20679501
Quantity per Package
10
Contains DI Package
M20679500
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |