Duns Number:801895244
Device Description: Apple-Hunt Secondary Cannula™ Pyramidal Tip; 12mm with 5mm & 10mm Reducers; Extended Lengt Apple-Hunt Secondary Cannula™ Pyramidal Tip; 12mm with 5mm & 10mm Reducers; Extended Length
Catalog Number
-
Brand Name
EMERGO EUROPE
Version/Model Number
900-851
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"
Yes
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
DRC
Product Code Name
Trocar
Public Device Record Key
205a761d-a4c1-4fcf-be17-082b706c56e8
Public Version Date
January 09, 2020
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
20888937003998
Quantity per Package
5
Contains DI Package
00888937003994
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |