Duns Number:081277700
Device Description: Gorney Septal Morselizer 8-1/4", Tungsten Carbide
Catalog Number
PM-2215
Brand Name
Integra® Miltex®
Version/Model Number
PM-2215
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 15, 2019
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
-
Product Code
KAE
Product Code Name
FORCEPS, ENT
Public Device Record Key
215392d5-6f57-4417-b3c7-cc1be2816f61
Public Version Date
February 05, 2020
Public Version Number
6
DI Record Publish Date
April 03, 2018
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 |