Duns Number:118492643
Device Description: SENTINEL CHEST TRAUMA KIT2 ea Sentinel Dual vent Chest seals with Sentinel 10x extreme str SENTINEL CHEST TRAUMA KIT2 ea Sentinel Dual vent Chest seals with Sentinel 10x extreme strength adhesive1 ea Dart sterile 14 gauge x 3.25" needle / catheter for chest decompression1 ea Dart Target 1 ea wipe
Catalog Number
20-510
Brand Name
Sentinel Chest Trauma Kit
Version/Model Number
03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 31, 2026
Issuing Agency
In HIBCC
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
824d1735-2e59-4fe5-be16-bbbcbf13b53b
Public Version Date
August 19, 2022
Public Version Number
3
DI Record Publish Date
September 13, 2018
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |