Duns Number:101147171
Device Description: SafeSiders Refill Size 25/06 25 mm NiTi
Catalog Number
5025-25/06
Brand Name
SafeSiders
Version/Model Number
5025-25/06
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
EKP
Product Code Name
REAMER, PULP CANAL, ENDODONTIC
Public Device Record Key
71581f08-864c-4177-9cf9-a7306679dfa2
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 17, 2020
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 | 249 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| U | Unclassified | 3 |