Duns Number:002348191
Device Description: GuideLiner V3 5.5F
Catalog Number
5570
Brand Name
GUIDELINER
Version/Model Number
IPN915840
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
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
b6e841bd-e7fa-433a-bf59-0a2245d874e0
Public Version Date
February 24, 2022
Public Version Number
1
DI Record Publish Date
February 16, 2022
Package DI Number
20841156109117
Quantity per Package
1
Contains DI Package
10841156109110
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 |