Duns Number:002348191
Device Description: HP TI SMALL SP 25 Clips/Cart w/Tape
Catalog Number
534735
Brand Name
WECK
Version/Model Number
IPN915135
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"
-
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
f8d8c92b-34dd-467e-863c-6bb6990ecbd8
Public Version Date
February 01, 2022
Public Version Number
4
DI Record Publish Date
January 11, 2021
Package DI Number
34026704696254
Quantity per Package
12
Contains DI Package
24026704696257
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 |