Duns Number:801895244
Device Description: Wallace SurePro Ultra Embryo Replacement Catheter w/ Stylet, Soft 23 cm (Box of 10)
Catalog Number
-
Brand Name
Wallace SurePro Ultra Embryo Replacement Catheter w/ Stylet
Version/Model Number
PES623
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"
Yes
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
MQF
Product Code Name
Catheter, Assisted Reproduction
Public Device Record Key
36cc507b-650f-4a39-bb61-c08ca0b47c62
Public Version Date
September 07, 2020
Public Version Number
2
DI Record Publish Date
December 04, 2019
Package DI Number
30888937021302
Quantity per Package
10
Contains DI Package
20888937021305
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |