Duns Number:002348191
Device Description: WECKVISTA ACCESS BALLOON PORT 10 MILLIMETER X 100 MILLIMETER
Catalog Number
410944L
Brand Name
WECK
Version/Model Number
IPN914268
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
K112456,K112456,K112456,K112456
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
39195cb8-29fd-4fba-8f38-6da9bd956ce5
Public Version Date
October 29, 2020
Public Version Number
3
DI Record Publish Date
April 16, 2019
Package DI Number
34026704645207
Quantity per Package
4
Contains DI Package
24026704645200
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 | 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 |