Duns Number:038000253
Device Description: 4F X 13CM DOUBLE LUMEN4F X 13CM INFUSION CATHETER SETINFUSION CA WITH MINI SCALPELWITH MIN 4F X 13CM DOUBLE LUMEN4F X 13CM INFUSION CATHETER SETINFUSION CA WITH MINI SCALPELWITH MINI SCALP
Catalog Number
DMC2LP-313S-ID
Brand Name
N/AN/A
Version/Model Number
DMC2LP-313S-ID
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2021
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"
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
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
943e67d0-5eb3-4e7d-87ac-bdba176ebde0
Public Version Date
July 14, 2021
Public Version Number
4
DI Record Publish Date
August 29, 2019
Package DI Number
50884908146849
Quantity per Package
10
Contains DI Package
00884908146844
Package Discontinue Date
June 24, 2021
Package Status
Not 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |