Duns Number:002348191
Device Description: WECKVISTA ACCESS BALLOON PORT 10 MILLIMETER X 70 MILLIMETER
Catalog Number
410944
Brand Name
TAUT
Version/Model Number
IPN914248
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
543e2152-719e-4cd9-85ef-d254d268e27c
Public Version Date
October 29, 2020
Public Version Number
3
DI Record Publish Date
April 16, 2019
Package DI Number
24026704645194
Quantity per Package
6
Contains DI Package
14026704645197
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 |