Duns Number:690540349
Device Description: Belmont Equipment, CHAIR, DENTAL, WITHOUT OPERATIVE UNIT
Catalog Number
AC-B50-V120V
Brand Name
Belmont Equipment (Chair)
Version/Model Number
Belmont Equipment (Chair)
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NRU
Product Code Name
Chair, Dental, Without Operative Unit
Public Device Record Key
44170089-c3e8-416f-b144-9c4e6dbb7f3c
Public Version Date
May 27, 2022
Public Version Number
2
DI Record Publish Date
March 12, 2021
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 | 72 |
2 | A medical device with a moderate to high risk that requires special controls. | 19 |