Duns Number:002348191
Device Description: PILLING GAR DENT TEETH GUARDS 3PR/B
Catalog Number
502276
Brand Name
PILLING
Version/Model Number
IPN007744
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
BRW
Product Code Name
Protector, dental
Public Device Record Key
b82d374d-c72d-454b-a842-590f72ed6a39
Public Version Date
July 23, 2020
Public Version Number
2
DI Record Publish Date
October 22, 2018
Package DI Number
24026704646719
Quantity per Package
3
Contains DI Package
14026704646712
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |