Duns Number:064783913
Device Description: "Dense foam cleans bio-debris easier and faster and holds Endo instruments in an upright p "Dense foam cleans bio-debris easier and faster and holds Endo instruments in an upright positionSquare shape fits great in procedure tubThicker foam prevents solution from leaking - has rounded corners for easy cleaningAvailable in black onlyDimensions: 1-7/8"" x 1-7/8"" x 1-1/4""Autoclavable up to 136°C/275°FWasher-disinfect"
Catalog Number
-
Brand Name
Assist Stand
Version/Model Number
50Z462
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
4e880741-311d-44a0-b17b-4743c82e0c43
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 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 |