Duns Number:076907973
Device Description: Equalizing Device is used when three or more digits are put in Traction. Constructed of d Equalizing Device is used when three or more digits are put in Traction. Constructed of durable composite plastic for ease of cleaning and ultimate strength. This device can be used with an IV Pole or other extremity systems. Includes cables for holding finger traps.
Catalog Number
MCM350
Brand Name
NA
Version/Model Number
MCM350
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FOX
Product Code Name
Stand, Infusion
Public Device Record Key
e5003d72-f0d9-4b82-b7ec-954c87bc83e8
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 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 | 342 |