Duns Number:119193803
Device Description: PRE-STERILIZED, SINGLE USE DENTAL MOUTH MIRRORS
Catalog Number
7158215
Brand Name
Classic Disposable Mouth Mirrors
Version/Model Number
7158215
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"
Yes
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
fbb4e666-612c-4d4b-819a-b8066e9d4dc5
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 23, 2021
Package DI Number
00723896019740
Quantity per Package
6
Contains DI Package
00723896019733
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 |