Duns Number:015903922
Device Description: Gruber Ear Specula, Oval, Adult, 3.2 x 4.7mm
Catalog Number
6.05.06
Brand Name
mytaMed
Version/Model Number
6.05.06
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 14, 2018
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EPY
Product Code Name
Speculum, Ent
Public Device Record Key
798a4466-ee5b-4863-9b04-0cd41e9a587f
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 14, 2018
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 | 861 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |