Duns Number:002348191
Device Description: HOL XL CLIPS, EXTRA LARGE, NS, 6 Clips/Cart
Catalog Number
544206
Brand Name
WECK
Version/Model Number
IPN009036
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
K133202,K133202,K133202
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
d5f9288c-3ab4-433a-bc51-f8fe2e797bb1
Public Version Date
August 17, 2022
Public Version Number
5
DI Record Publish Date
October 16, 2015
Package DI Number
24026704601114
Quantity per Package
20
Contains DI Package
14026704601117
Package Discontinue Date
August 11, 2022
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 |