Duns Number:064783913
Device Description: "Crystal HD Assorted Thin Grip 12pk-Jewel #42 x Plum2 x Midnight Blue2 x Gray2 x Teal2 x R "Crystal HD Assorted Thin Grip 12pk-Jewel #42 x Plum2 x Midnight Blue2 x Gray2 x Teal2 x Red2 x Copper"
Catalog Number
-
Brand Name
Crystal HD® Mouth Mirrors
Version/Model Number
50Z353-JWL
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
b10943c4-5c8c-44f4-9f91-f9eedd22f5b3
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 07, 2022
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 | 399 |