Duns Number:216603021
Device Description: Pack of 5 pouches, each containing 2 geko T-3 devices. Instructions and patient informatio Pack of 5 pouches, each containing 2 geko T-3 devices. Instructions and patient information in each pack
Catalog Number
T3USP2-05
Brand Name
geko
Version/Model Number
T-3
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"
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
K181059,K181059
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
0a7c879e-92a5-41fc-ad45-4f3a81dfd1c0
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
July 06, 2020
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. | 6 |