Duns Number:804085293
Device Description: Wound Care Kit, Value Pack, 25 items, assorted sizes: 8 - Gauze Pads 4 IN x 4 IN (101 mm x Wound Care Kit, Value Pack, 25 items, assorted sizes: 8 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 4 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 4 - Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 4 - Non-stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m); 1 – Paper Tape 1 IN x 10 YD (25 mm x 9.14 m).
Catalog Number
-
Brand Name
Core Values
Version/Model Number
017276236668
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
cb86d47d-ccab-4351-b2aa-6c4ce5b9ac30
Public Version Date
April 28, 2020
Public Version Number
1
DI Record Publish Date
April 20, 2020
Package DI Number
10017276236665
Quantity per Package
36
Contains DI Package
00017276236668
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |