Duns Number:428755441
Device Description: A disposable universal dentist chair cover for the protection and safety of patients. Kit A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: lime
Catalog Number
264006
Brand Name
Monoart
Version/Model Number
KIT MONOART DENTIST CHAIR COVER
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
NRU
Product Code Name
Chair, Dental, Without Operative Unit
Public Device Record Key
1486cf1b-6c4c-4148-ba30-9393d94e243e
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
E3072640062
Quantity per Package
3
Contains DI Package
E3072640060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 126 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |