Duns Number:835465063
Device Description: STYLETS 3118515 10PK IRRIGATION
Catalog Number
-
Brand Name
NA
Version/Model Number
3118515
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2018
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
K791407,K791407
Product Code
ERL
Product Code Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Public Device Record Key
d6ea6070-970e-4f25-b1bb-a61c389269b5
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
May 02, 2016
Package DI Number
20681490069292
Quantity per Package
10
Contains DI Package
00681490069298
Package Discontinue Date
October 24, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |