Duns Number:002348191
Device Description: WECKVISTA OPTICAL PORT 5 MILLIMETERX100 MILLIMETER RIDGED
Catalog Number
40511R
Brand Name
TAUT
Version/Model Number
IPN914256
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
K010007,K010007,K010007,K010007
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
3700f0ee-dfd4-490a-acc6-ef3356d1be35
Public Version Date
October 29, 2020
Public Version Number
3
DI Record Publish Date
April 16, 2019
Package DI Number
34026704645023
Quantity per Package
4
Contains DI Package
24026704645026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |