Duns Number:841842441
Device Description: Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surger Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.
Catalog Number
HOP-AP
Brand Name
Hemorrhage Occluder Pin with Applicator
Version/Model Number
HOP-AP
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040109
Product Code
GDW
Product Code Name
Staple, Implantable
Public Device Record Key
732b824a-c3a3-450e-bb16-e13223a30e03
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 26, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |