Duns Number:687503532
Device Description: Pack tip (60/05L)
Catalog Number
-
Brand Name
EQ-V
Version/Model Number
EQV-P24
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2021
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
EKR
Product Code Name
Plugger, Root Canal, Endodontic
Public Device Record Key
897298aa-45c3-4336-94bf-c6a0a0f3e15b
Public Version Date
April 22, 2021
Public Version Number
2
DI Record Publish Date
March 02, 2020
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 | 36 |
U | Unclassified | 11 |