Duns Number:051957769
Device Description: Burn Care First Aid Kit, 8 pieces: 1- Triple Antibiotic Ointments 1/32 OZ (0.9 g); 1 – Fir Burn Care First Aid Kit, 8 pieces: 1- Triple Antibiotic Ointments 1/32 OZ (0.9 g); 1 – First Aid & Burn Cream 1/32 OZ (0.9 g); 2 - 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 1- Carrying Case; 1 - Hydrogel Burn Pad 1.96 IN x 2.96 IN (49 mm x 74 mm); 1 - Paper Tape 1/2 IN x 5 YDS (12.7 mm x 4.5 m); 1 - Non-Stick Pad 2 IN x 3 IN (50 mm x 76 mm)
Catalog Number
-
Brand Name
Ozark Trail Outdoor Equipment
Version/Model Number
017276235876
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJI
Product Code Name
Burn Kit With Drug
Public Device Record Key
a50b034a-2149-450d-b4d8-0354f922dce3
Public Version Date
August 16, 2021
Public Version Number
2
DI Record Publish Date
December 16, 2019
Package DI Number
20017276235870
Quantity per Package
12
Contains DI Package
00017276235876
Package Discontinue Date
January 25, 2021
Package Status
Not 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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |