Duns Number:058614483
Device Description: Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.038"" x 27.7"" (0.965 m Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.038"" x 27.7"" (0.965 mm x 70 cm)
Catalog Number
8813796001
Brand Name
Argyle
Version/Model Number
8813796001
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
K770977,K770977
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
4f681678-9f99-4365-ae24-005643a1e3ad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20884521003962
Quantity per Package
10
Contains DI Package
10884521003965
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 |