Duns Number:486711679
Device Description: 1.7MM DRILL BIT WITH 5MM STOP J-LATCH F/RAPIDSORB IPS-STER
Catalog Number
310405S
Brand Name
RapidSorb
Version/Model Number
310.405S
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
Yes
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
K043310
Product Code
HBE
Product Code Name
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
Public Device Record Key
bb6df91a-97df-4ef2-80ce-454f9d83c651
Public Version Date
April 25, 2022
Public Version Number
5
DI Record Publish Date
October 07, 2016
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |