Duns Number:064783913
Device Description: "Built-in millimeter gauge measures files and positions rubber stopperRight or left hand u "Built-in millimeter gauge measures files and positions rubber stopperRight or left hand useSmall and large rings are included to accommodate most finger sizesFlat bottom enables the Endo Assist to stand freely on its ownComes with 12 disposable foam insertsFoam cleans and holds filesDesigned to slide into side of the Endo GuardsDimensions: 1-1/2"" x 1-3/4"" x 1-5/8""Autoclavable up to 136°C/275°FWasher-disinfect"
Catalog Number
-
Brand Name
Endo Assist Neon Orange
Version/Model Number
50Z460Q
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
df3d6975-6ae3-4046-bde6-75c220622cac
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 |