Duns Number:002348191
Device Description: HP TI ML 10 Clips/Cart w/Tape
Catalog Number
533860
Brand Name
WECK
Version/Model Number
IPN028156
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,K132658
Product Code
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
bc11e515-3719-4cc6-a0d7-6384c6c2974d
Public Version Date
May 16, 2022
Public Version Number
7
DI Record Publish Date
September 27, 2018
Package DI Number
54026704625098
Quantity per Package
12
Contains DI Package
44026704625091
Package Discontinue Date
April 26, 2022
Package Status
Not 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 |