Duns Number:012430880
Device Description: Disposable Dental Bib Holder
Catalog Number
5702004
Brand Name
Henry Schein
Version/Model Number
5702004
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
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
NRD
Product Code Name
Unit, operative dental, accessories
Public Device Record Key
54734945-20b8-4727-ae18-1962ddf528c9
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
20304040132153
Quantity per Package
40
Contains DI Package
10304040132156
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |