Duns Number:082594540
Device Description: FERGUSON-FRAZIER Suction Tube, angled, 6 1/2", (160 mm), (100 mm), 14FR, non-sterile, reus FERGUSON-FRAZIER Suction Tube, angled, 6 1/2", (160 mm), (100 mm), 14FR, non-sterile, reusable
Catalog Number
MA508R
Brand Name
AESCULAP
Version/Model Number
MA508R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 12, 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)
-
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
JZF
Product Code Name
TUBE, EAR SUCTION
Public Device Record Key
563b4f0b-dffd-44a4-8ef0-377071541caf
Public Version Date
May 28, 2021
Public Version Number
2
DI Record Publish Date
May 08, 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 |