Duns Number:070556204
Device Description: Curaplex TOCS: Tactical Occlusive Chest Seal
Catalog Number
1215-22195
Brand Name
Curaplex
Version/Model Number
1215-22195
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
NAE
Product Code Name
Dressing, wound, hydrogel without drug and/or biologic
Public Device Record Key
8b011999-2a3f-48e4-a001-417e297532d8
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
February 10, 2019
Package DI Number
00812277034240
Quantity per Package
25
Contains DI Package
00812277034226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |