Duns Number:002348191
Device Description: VISISTAT 35R 6/BOX
Catalog Number
528135
Brand Name
WECK
Version/Model Number
IPN028492
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
GDT
Product Code Name
STAPLE, REMOVABLE (SKIN)
Public Device Record Key
49facf23-9bed-427d-9759-9e595609c4be
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
April 11, 2019
Package DI Number
54026704631778
Quantity per Package
10
Contains DI Package
44026704631771
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 |