Duns Number:053947946
Device Description: 527 Exam/Procedure Chair, 115V
Catalog Number
5270001
Brand Name
MTI
Version/Model Number
5270001
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
GBB
Product Code Name
Chair, Surgical, Ac-Powered
Public Device Record Key
27d81d36-a989-46ac-809d-e76a5b8cb33f
Public Version Date
February 11, 2020
Public Version Number
1
DI Record Publish Date
February 03, 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 | 300 |