Duns Number:002348191
Device Description: WECK EFx Shield Port Site Closure System
Catalog Number
EFX002
Brand Name
WECK
Version/Model Number
IPN923663
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
HCF
Product Code Name
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Public Device Record Key
a521e4ba-3358-4825-b1e8-c5dc22214027
Public Version Date
February 04, 2022
Public Version Number
1
DI Record Publish Date
January 27, 2022
Package DI Number
34026704739005
Quantity per Package
8
Contains DI Package
24026704739008
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 |