Duns Number:009127838
Device Description: Motor Control, ProStyle E, reversing, with hose
Catalog Number
13186
Brand Name
Lares Research
Version/Model Number
Control, Motor, ProStyle E, Electric FO E-Type
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042759
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
e7350d81-ae22-45b7-8204-2d4551806eb0
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |