Duns Number:062165188
Device Description: MOUTH MIRROR SIZE #5 WITH HOLLOW FORM HANDLE
Catalog Number
-
Brand Name
MOUTH MIRROR
Version/Model Number
4150-980
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)
Yes
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
2603b272-e2fa-4875-9946-e2012eedc2c5
Public Version Date
July 21, 2020
Public Version Number
1
DI Record Publish Date
July 13, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8511 |
2 | A medical device with a moderate to high risk that requires special controls. | 1527 |