Duns Number:801895244
Device Description: Closed End, Open Side, Extra Fine Cannula, 3.5 Fr OD
Catalog Number
-
Brand Name
Insemination Cannula with Syringe
Version/Model Number
MX732
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
K910317,K910317
Product Code
MFD
Product Code Name
Cannula, Intrauterine Insemination
Public Device Record Key
0d670eb3-6399-4427-8bb2-1f70111ac764
Public Version Date
January 23, 2019
Public Version Number
5
DI Record Publish Date
March 21, 2016
Package DI Number
20888937001222
Quantity per Package
24
Contains DI Package
00888937001228
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |