Duns Number:042823948
Device Description: Tefcat Embryo Transfer Catheter
Catalog Number
K-TFCT-401500
Brand Name
Tefcat
Version/Model Number
G32719
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 04, 2019
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
MQF
Product Code Name
CATHETER, ASSISTED REPRODUCTION
Public Device Record Key
dd52d6ef-53f3-44d4-8a85-26be90a23c33
Public Version Date
September 05, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10827002327198
Quantity per Package
10
Contains DI Package
00827002327191
Package Discontinue Date
September 04, 2019
Package Status
Not 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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |