Duns Number:544436531
Device Description: It is a product can be used as medical purposes specified in Intended use and it is easy t It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustableit is designed with below feature:- Dual function, including separation fingers and training fingers- Aluminum alloy make good supporting- Extractable aluminum alloy is, for easy cleaning and adjustment- Velcro is vertical arrangementfor easy wearing
Catalog Number
-
Brand Name
Konmed
Version/Model Number
KM-W-35
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LQX
Product Code Name
Device, Finger-Sucking
Public Device Record Key
2c600f43-11f6-4688-bfca-5893417ca4ca
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
January 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |