Duns Number:002348191
Device Description: WECKVISTA 12 MILLIMETER X 125 CONE OPEN ACCES
Catalog Number
405933L
Brand Name
WECK
Version/Model Number
IPN914266
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
a197ea4f-8056-49a6-86b3-0f60ca6dc7a1
Public Version Date
October 29, 2020
Public Version Number
3
DI Record Publish Date
April 16, 2019
Package DI Number
24026704645170
Quantity per Package
6
Contains DI Package
14026704645173
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 |