Duns Number:119193803
Device Description: Easily handled mouth mirrors for dental use
Catalog Number
-
Brand Name
Practicon VersaGrip Mouth Mirrors
Version/Model Number
701793
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
-
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
EAX
Product Code Name
Mirror, Mouth
Public Device Record Key
02df224a-5851-4aa6-ab85-e57267aa02cc
Public Version Date
April 14, 2021
Public Version Number
1
DI Record Publish Date
April 06, 2021
Package DI Number
00723896019481
Quantity per Package
20
Contains DI Package
00723896019474
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |