Duns Number:038000253
Device Description: 0.018" (0.47MM) X 80CM0.018" (0. STAINLESS STEEL GUIDEWIRESTAINLE W/SILICONE COATINGW/SILI 0.018" (0.47MM) X 80CM0.018" (0. STAINLESS STEEL GUIDEWIRESTAINLE W/SILICONE COATINGW/SILICONE COA
Catalog Number
DG80
Brand Name
VASCUPUNCTUREVASCUPUNCTURE
Version/Model Number
DG80
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"
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
K031652,K031652,K031652
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
0ed5bd2f-7978-4854-a87b-f31bff3eef2b
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 04, 2019
Package DI Number
30884908145138
Quantity per Package
5
Contains DI Package
00884908145137
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner 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 |