Duns Number:081277700
Device Description: KIRSCH, SINUS 7 DBL ENDED, SPOON, PLUGGER
Catalog Number
62-304
Brand Name
Miltex®
Version/Model Number
62-304
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 20, 2017
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
K092855
Product Code
DZL
Product Code Name
SCREW, FIXATION, INTRAOSSEOUS
Public Device Record Key
4a2b56db-bbdd-48e2-95d4-8c07e9d09ca1
Public Version Date
January 22, 2021
Public Version Number
6
DI Record Publish Date
September 22, 2015
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |