Duns Number:076907973
Device Description: Extra Wide Armboard Pad for MCM442. 2" thick standard foam with lectrolyte cover and sewn Extra Wide Armboard Pad for MCM442. 2" thick standard foam with lectrolyte cover and sewn in velcro on lower side to secure to armboard..
Catalog Number
MCM443
Brand Name
NA
Version/Model Number
MCM443
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
NOD
Product Code Name
Board, Arm (With Cover), Non-Sterile
Public Device Record Key
b527fb34-9e23-4c82-abb7-47fbdbb5c5ac
Public Version Date
November 19, 2020
Public Version Number
2
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 |