Duns Number:082594540
Device Description: FRAZIER Suction Tube, straight, 5 1/2", (140 mm), (95 mm), 9FR, non-sterile, reusable
Catalog Number
MA501R
Brand Name
AESCULAP
Version/Model Number
MA501R
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
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
763e497e-8b3a-439d-a818-979f2556b257
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 2020
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 |