Duns Number:079700711
Device Description: 2.3 mm Drill Bit, Non-Sterile
Catalog Number
-
Brand Name
In2Bones USA
Version/Model Number
P04 N0241
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
ee8c4961-de93-4871-9ca4-4d1f7165de32
Public Version Date
August 08, 2019
Public Version Number
1
DI Record Publish Date
July 31, 2019
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 | 113 |
2 | A medical device with a moderate to high risk that requires special controls. | 1255 |