Duns Number:038000253
Device Description: 0.010" (0.26MM) X 40CM0.010" (0. NITINOL GUIDEWIRENITINOL GUIDEWI
Catalog Number
-
Brand Name
GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE
Version/Model Number
MR190040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 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
K021990,K021990,K021990
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
f5dce1f5-4f3e-48d8-9edb-24d9c34efb67
Public Version Date
February 03, 2021
Public Version Number
4
DI Record Publish Date
December 02, 2017
Package DI Number
30884908105279
Quantity per Package
10
Contains DI Package
00884908105278
Package Discontinue Date
January 29, 2021
Package Status
Not 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 |