Duns Number:071595540
Device Description: 2MM (5/64 IN) TWIST DRILL WITH STOP, 4 EA
Catalog Number
8733
Brand Name
NA
Version/Model Number
8733
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
GFG
Product Code Name
BIT, SURGICAL
Public Device Record Key
8195cdd5-b523-4b76-8a2f-f7f1b5a230cb
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10845854025529
Quantity per Package
4
Contains DI Package
20845854025526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |