Duns Number:082594540
Device Description: FRAZIER Suction Tube, angled, 7", (180 mm), 6FR, non-sterile, reusable
Catalog Number
MF512R
Brand Name
AESCULAP
Version/Model Number
MF512R
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
1a3c8b17-f3d2-4a6b-97b1-d9df1f05e00d
Public Version Date
October 04, 2021
Public Version Number
4
DI Record Publish Date
September 24, 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 | 3239 |
2 | A medical device with a moderate to high risk that requires special controls. | 683 |