Duns Number:192559557
Device Description: HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F
Catalog Number
MPL2T-1430H
Brand Name
GP General Purpose Drainage Catheter
Version/Model Number
MPL2T-1430H
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 2022
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"
Yes
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
GBO
Product Code Name
Catheter, Nephrostomy, General & Plastic Surgery
Public Device Record Key
78c0b121-b514-43d6-a0cd-a42ea5522b55
Public Version Date
April 28, 2022
Public Version Number
2
DI Record Publish Date
June 10, 2021
Package DI Number
H862MPLT21430H1
Quantity per Package
5
Contains DI Package
H862MPLT21430H0
Package Discontinue Date
April 27, 2022
Package Status
Not in Commercial Distribution
Package Type
Dispenser
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 179 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
U | Unclassified | 24 |