Duns Number:688398443
Device Description: InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of b InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation.
Catalog Number
-
Brand Name
InnoSEAL Hemostatic Pad
Version/Model Number
IS-H-01-10
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
K161013,K161013
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
f1789249-04d8-4412-8f71-c9ebad06ecf9
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
May 07, 2019
Package DI Number
08800030700145
Quantity per Package
10
Contains DI Package
08800030700121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CCP paper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 1 |