Duns Number:196548481
Device Description: 4.0 mm ENT Precision Cutter Angle Agg. Serr 60 Degree ESSx/HUMMER 4 11.0 cm Working Length
Catalog Number
5290-640-100
Brand Name
NA
Version/Model Number
5290640100
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
ERL
Product Code Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Public Device Record Key
318e979d-1326-4cc5-bb89-4f202f1f6115
Public Version Date
January 22, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
37613154631910
Quantity per Package
5
Contains DI Package
07613154631919
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 |