Duns Number:064783913
Device Description: "Holds most lengths for staging, cleaning, sterilizing files and reamersMillimeter gauge m "Holds most lengths for staging, cleaning, sterilizing files and reamersMillimeter gauge measures files and positions rubber stopperRight or left hand useSingle foam insert cleans and holds filesSterilization counter on locking bar tracks the number of times instruments have been sterilizedOrganizes up to 11 Engine and 5 Hand filesDimensions: 5-3/8"" x 3/8"" x 2-3/16""Autoclavable up to 136°C/275°FWasher-disinfect"
Catalog Number
-
Brand Name
Steri-Endo Guard Copper
Version/Model Number
50Z452U
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
103f9012-127d-4af1-8d78-01982c052429
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 |