Duns Number:832696038
Device Description: SUCTION INSTRUMENT 3.2MM TUBE, YANKAUER HANDLE WORKING LENGTH 6.75" (17CM) OVERALL LENGTH SUCTION INSTRUMENT 3.2MM TUBE, YANKAUER HANDLE WORKING LENGTH 6.75" (17CM) OVERALL LENGTH 12.25" (31CM)
Catalog Number
CH8201
Brand Name
V. Mueller
Version/Model Number
CH8201
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
-
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
96cb093b-2571-4093-8bdb-ee405c065f69
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
August 17, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |