Duns Number:315018218
Device Description: MINOP Suction Cannula, 45 °, straight, diam. 2 mm, sharp, sterile, disposable, to be used MINOP Suction Cannula, 45 °, straight, diam. 2 mm, sharp, sterile, disposable, to be used with: FF399R
Catalog Number
FH607SU
Brand Name
MINOP
Version/Model Number
FH607SU
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
Yes
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
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
801a42ab-e179-4ce2-bf6a-de17fed4396a
Public Version Date
January 13, 2021
Public Version Number
2
DI Record Publish Date
April 23, 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 | 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 |