Duns Number:119193803
Device Description: snap onto size 4 and size 5 mouth mirrors and feature twin tabs to keep both lingual and b snap onto size 4 and size 5 mouth mirrors and feature twin tabs to keep both lingual and buccal cotton rolls in place during lower posterior procedures. Easily reversible for left or right quadrants. 100 single-use, disposable holders per bag. Not for use with Zirc mouth mirrors.
Catalog Number
70-42625
Brand Name
Mirror Cotton Holders
Version/Model Number
1604-P01
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
1fb1bd09-f843-4d59-8164-506dd0fa0cbd
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896010075
Quantity per Package
120
Contains DI Package
00723896010068
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 |