Duns Number:190572854
Device Description: DISTAL RIB CLEAR CANNULA WITH OBTURATOR 5.5mm x 75mm
Catalog Number
214107
Brand Name
NA
Version/Model Number
214107
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
GEA
Product Code Name
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
6818391f-a10a-484a-a391-1b14d40b4440
Public Version Date
July 22, 2020
Public Version Number
3
DI Record Publish Date
September 01, 2015
Package DI Number
20886705003485
Quantity per Package
5
Contains DI Package
10886705003488
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |