Duns Number:038000253
Device Description: 20G X 5/8" (15MM) PRO-LOCK20G X CT SAFETY INFUSION SETCT SAFETY
Catalog Number
MRH2063
Brand Name
20G X 5/8" PRO-LOCK CT SAFETY INFUSION SET20G X 5/8" PRO-LOCK CT SAFETY INFUSION
Version/Model Number
MRH2063
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
PTI
Product Code Name
Non-Coring (Huber) Needle
Public Device Record Key
65edf93b-74de-477e-bd1d-cd248ddba4f5
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
February 06, 2019
Package DI Number
50884908127787
Quantity per Package
8
Contains DI Package
30884908127783
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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 2560 |