Duns Number:101571834
Device Description: Halo Seal IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, Halo Seal IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to cover a wound and to provide a mechanical barrier. Each package contains quantity: 2 Halo Seals.
Catalog Number
1216-10010
Brand Name
Halo
Version/Model Number
1216-10010
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
2e3ae197-da36-4393-a303-6df4688af99e
Public Version Date
March 10, 2021
Public Version Number
1
DI Record Publish Date
March 02, 2021
Package DI Number
00850010608075
Quantity per Package
200
Contains DI Package
00850010608068
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |