Duns Number:176528040
Device Description: 1139 -1.000 EACH 10 Unit Kit Empty Plastic3160 -2.000 EACH WJ Burn Dressing 4x47920 -1.000 1139 -1.000 EACH 10 Unit Kit Empty Plastic3160 -2.000 EACH WJ Burn Dressing 4x47920 -1.000 EACH Glove Wipes20669 -1.000 EACH Burn Cream w/Lidocaine Unit (13002 -1.000 EACH GG Derma Cool (2 oz.)6117 -1.000 EACH 3" Sterile Gauze Roll9010B -1.000 EACH Burn Relief Kit Stickers6253 -1.000 EACH Waterproof Tape 1/2" x 5yds6205 -1.000 EACH GG 3x3 Gauze Pads (10)
Catalog Number
1197
Brand Name
Green Guard Small Burn Kit
Version/Model Number
1197
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)
-
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
eacbe860-6b59-43f5-bf66-2709584dea9d
Public Version Date
September 10, 2019
Public Version Number
2
DI Record Publish Date
July 15, 2019
Package DI Number
50347682011975
Quantity per Package
1
Contains DI Package
00347682011970
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |