Duns Number:196548481
Device Description: Drill Bit 2.0mm (5/64'') x 128.0mm, Non-Sterile
Catalog Number
0277-082-085S7
Brand Name
NA
Version/Model Number
0277082085S7
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
-
Product Code
GFG
Product Code Name
BIT, SURGICAL
Public Device Record Key
92e2bf7b-8d41-4d75-8db4-faed13dff110
Public Version Date
January 17, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2018
Package DI Number
37613153089026
Quantity per Package
6
Contains DI Package
07613153089025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |