Duns Number:012430880
Device Description: Bur Block Plastic 8 Hole
Catalog Number
5700423
Brand Name
Henry Schein
Version/Model Number
5700423
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"
Yes
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
EIF
Product Code Name
ACCESSORIES, RETRACTOR, DENTAL
Public Device Record Key
54506bf1-1457-4c83-a909-7640c02f12e8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 30, 2017
Package DI Number
10304040039455
Quantity per Package
50
Contains DI Package
00304040039458
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |