Duns Number:071595540
Device Description: FRAZIER Suction Instrument 18 Fr W/Obturator, No Control Vent
Catalog Number
0033180
Brand Name
FRAZIER
Version/Model Number
0033180
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
10316fe4-e66e-452f-a239-ac8c7898db96
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405000157
Quantity per Package
10
Contains DI Package
30653405000154
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 |