Duns Number:024954518
Device Description: 0.014" Shepherd ES Guidewire - straight 195 cm - 12 gms
Catalog Number
7-10097-01
Brand Name
Shepherd
Version/Model Number
PSP14S-19512
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
-
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
585f79cb-84cb-475d-86e0-2c4dda54a525
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 2022
Package DI Number
30850026568616
Quantity per Package
5
Contains DI Package
10850026568612
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |
| 3 | A medical device with high risk that requires premarket approval | 15 |