Duns Number:002348191
Device Description: DURAHOOK 1/4 HOOK 10 PACKAGES PER BOX /6 HOOKS PER PACKAGE
Catalog Number
382800
Brand Name
WECK
Version/Model Number
IPN006431
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
HAO
Product Code Name
INSTRUMENT, SURGICAL, NON-POWERED
Public Device Record Key
1b29b69f-3560-469a-9eef-c983504f5fa5
Public Version Date
January 29, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2018
Package DI Number
44026704599743
Quantity per Package
10
Contains DI Package
24026704599749
Package Discontinue Date
January 20, 2020
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 |