Duns Number:002348191
Device Description: GrebSet micro-introducer kit
Catalog Number
7950
Brand Name
GREBSET
Version/Model Number
IPN001740
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
-
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
f17af086-6e4d-477a-9f6b-f316a36090d9
Public Version Date
February 04, 2020
Public Version Number
1
DI Record Publish Date
January 27, 2020
Package DI Number
20841156105874
Quantity per Package
10
Contains DI Package
10841156105877
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |