Duns Number:078294927
Device Description: Guidewire 3-Pack
Catalog Number
-
Brand Name
Guidewire 3-Pack
Version/Model Number
MD0630-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K180981
Product Code
GZB
Product Code Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Public Device Record Key
a17112e3-d11e-4db3-a445-4109444d8757
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 25, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 58 |