Duns Number:192559557
Device Description: HYDROPHILIC COATED MINI-PIGTAIL LOCKING CATHETER WITH DEPTH MARKS, 12F
Catalog Number
MPL2-1230H
Brand Name
GP General Purpose Drainage Catheter
Version/Model Number
MPL2-1230H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 28, 2027
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
68997a9a-fa94-41cd-8d8c-75611383d93c
Public Version Date
April 29, 2022
Public Version Number
2
DI Record Publish Date
June 09, 2021
Package DI Number
H862MPL21230H1
Quantity per Package
5
Contains DI Package
H862MPL21230H0
Package Discontinue Date
February 28, 2027
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 |