Duns Number:058614483
Device Description: Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm
Catalog Number
8815642001
Brand Name
Argyle
Version/Model Number
8815642001
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
K862288,K862288
Product Code
DRE
Product Code Name
DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Public Device Record Key
c7e0794e-e912-44e4-91eb-cffc8a7af34d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 13, 2016
Package DI Number
20884521004006
Quantity per Package
5
Contains DI Package
10884521004009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |