Duns Number:064783913
Device Description: Instrument holder intended to hold 8 instruments during cleaning, sterilization and set-up Instrument holder intended to hold 8 instruments during cleaning, sterilization and set-up. Includes a syringe holder.
Catalog Number
50Z927R
Brand Name
E-Z Jett Cassette
Version/Model Number
8-Place, R-N.Purple
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
b9bef6d5-b765-4fee-bfd7-82bcc0c7c895
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
September 24, 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 | 399 |