Duns Number:002348191
Device Description: GAR DENT TEETH GUARDS 3 PAIR/BOX
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
KBN
Product Code Name
GAG, MOUTH
Public Device Record Key
af66b247-f9da-4c9a-98a3-7c85acc2d5c7
Public Version Date
October 16, 2018
Public Version Number
1
DI Record Publish Date
September 15, 2018
Package DI Number
44026704600333
Quantity per Package
3
Contains DI Package
24026704600339
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 |