Duns Number:002348191
Device Description: WattsonGuidewire,280cm
Catalog Number
2250
Brand Name
WATTSON
Version/Model Number
IPN914275
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
2a1ea03a-0bea-492b-9a9d-8a2d2b2c4be1
Public Version Date
February 04, 2020
Public Version Number
1
DI Record Publish Date
January 27, 2020
Package DI Number
20841156106499
Quantity per Package
1
Contains DI Package
10841156106492
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |