Duns Number:592534619
Device Description: Support Furniture
Catalog Number
AM0420
Brand Name
Adept Medical IR platform + Extension
Version/Model Number
AM0420
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 29, 2017
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
KMN
Product Code Name
Chair And Table, Medical
Public Device Record Key
bebf6f40-84f3-459c-aa9e-f3597ad38e11
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2017
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 | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 33 |