Duns Number:071595540
Device Description: FRAZIER Olive Tip Suction Instrument 10 Fr W/Control Vent & Obturator
Catalog Number
0033110
Brand Name
FRAZIER
Version/Model Number
0033110
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
GCX
Product Code Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Public Device Record Key
d56ac41e-fbb5-4b64-b97c-640ed9dcebc7
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405000133
Quantity per Package
10
Contains DI Package
30653405000130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |