Duns Number:277619636
Device Description: HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows he HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar.
Catalog Number
LAP01-US
Brand Name
HEMOBLAST Bellows Laparoscopic Applicator
Version/Model Number
LAP01-US
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P170012,P170012,P170012
Product Code
PMX
Product Code Name
Absorbable Collagen Hemostatic Agent With Thrombin
Public Device Record Key
effcbdef-41a2-4b53-8317-d39f75af687e
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
February 28, 2019
Package DI Number
23760193182662
Quantity per Package
6
Contains DI Package
03760193182668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |