Duns Number:064783913
Device Description: "Holds 8 instrumentsCompact size, fits the statimMaximizes the space of the Ultrasonic and "Holds 8 instrumentsCompact size, fits the statimMaximizes the space of the Ultrasonic and AutoclaveCovers are attached to the cassette and open and fold back easilySyringe Tip comes with to attach to the side of the cassetteDimensions: 7-1/16"" x 4-1/16"" x 1-5/16""Contains Antimicrobial ProtectionAutoclavable up to 136°C/277F°Washer-disinfect"
Catalog Number
-
Brand Name
E-Z Jett Cassette Slim 8-place Neon Yellow
Version/Model Number
50Z911O
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
e63f63fa-0fb2-443c-8b73-d258116bad2d
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 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 |