Duns Number:315018218
Device Description: Suction Cannula, 14", (350 mm), diam. 2 mm, 3,50 mm, rubber tip, luer hub, non-sterile, re Suction Cannula, 14", (350 mm), diam. 2 mm, 3,50 mm, rubber tip, luer hub, non-sterile, reusable, for suction hose 6 - 9 mm
Catalog Number
OP031R
Brand Name
AESCULAP
Version/Model Number
OP031R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2021
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
4aa39514-1c11-47d6-835f-a60dee6558ae
Public Version Date
October 27, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |