Duns Number:071595540
Device Description: POOLE Suction Instrument W/Removable Sheath and 6 Foot (1.8m) Tubing, BNS
Catalog Number
9035050
Brand Name
POOLE
Version/Model Number
9035050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2020
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
8296bc3e-f758-49d8-81ec-7efac5136a0a
Public Version Date
June 08, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20653405014949
Quantity per Package
60
Contains DI Package
30653405014946
Package Discontinue Date
December 17, 2020
Package Status
Not 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 |