Duns Number:119193803
Device Description: Our Disposable Mouth Mirrors make nice giveaways for patient home care while helping reduc Our Disposable Mouth Mirrors make nice giveaways for patient home care while helping reduce sterilization time and expense. Front surface acrylic mirror with white plastic octagonal handle.
Catalog Number
7087210
Brand Name
Disposable Mouth Mirrors
Version/Model Number
A002-1 STERILE
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
8444c518-3d3b-463c-9550-65d0d184e932
Public Version Date
August 08, 2022
Public Version Number
3
DI Record Publish Date
July 19, 2018
Package DI Number
00723896010655
Quantity per Package
36
Contains DI Package
00723896010648
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 |