Duns Number:002348191
Device Description: HEMOCLIP TA ML 10 Clips/Cart
Catalog Number
523360
Brand Name
WECK
Version/Model Number
IPN008587
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K132658,K132658,K132658,K132658
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
7f1ed84b-14d2-4056-91f7-2b9eb47d810e
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 30, 2016
Package DI Number
24026704417999
Quantity per Package
16
Contains DI Package
04026704417995
Package Discontinue Date
October 18, 2017
Package Status
Not 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 |