Duns Number:012430880
Device Description: Caries Indicator 1.2 mL Green Syringe Kit With 20 Tips 4/Bx
Catalog Number
5702072
Brand Name
Henry Schein
Version/Model Number
5702072
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LFC
Product Code Name
DEVICE, CARIES DETECTION
Public Device Record Key
142232de-c278-45d2-8cd3-3daf9f8f3ba9
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 2020
Package DI Number
10304040133429
Quantity per Package
4
Contains DI Package
00304040133422
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 |