Duns Number:064783913
Device Description: Stainless Steel Head #3 12pk, 40% brighter than rhodium mirrors, Lens is flush with mirror Stainless Steel Head #3 12pk, 40% brighter than rhodium mirrors, Lens is flush with mirror frame, eliminating the possibility of corrosion build-up, Cone Socket
Catalog Number
-
Brand Name
Crystal HD® Mirrror Heads
Version/Model Number
50R379
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
bc77d084-6362-480c-ad84-b74a5df5fe7f
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 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 |