Duns Number:119193803
Device Description: Our vibrant NiceTouch Disposable Mouth Mirrors reduce sterilization expense and serve as a Our vibrant NiceTouch Disposable Mouth Mirrors reduce sterilization expense and serve as a fun yet functional giveaway. Great for use in conjunction with disclosing tablets and for helping your ortho patients apply wax and elastics. Pull-off film tabs keep mirrors scratch-free. Ergonomic handle features extra-strong neck. Unbreakable acrylic size 5 mirror.
Catalog Number
70-7213
Brand Name
NiceTouch Disposable Mouth Mirrors
Version/Model Number
10405-P
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)
-
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
c5d280ba-025d-4ba3-be64-f746060131fa
Public Version Date
December 21, 2018
Public Version Number
2
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010600
Quantity per Package
10
Contains DI Package
00723896010594
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 |