Duns Number:063997360
Device Description: Rolled Gauze for Securing a Dressing; Protects and Cushions; Latex Free; 1 Sterile Roll; U Rolled Gauze for Securing a Dressing; Protects and Cushions; Latex Free; 1 Sterile Roll; Unstretched; 3 IN. x 2.5 YDS
Catalog Number
2256881
Brand Name
LEADER
Version/Model Number
2256881
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
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
3ff2b748-0e14-44c2-8519-c8427362c992
Public Version Date
July 02, 2021
Public Version Number
2
DI Record Publish Date
April 18, 2019
Package DI Number
50096295102838
Quantity per Package
24
Contains DI Package
00096295102833
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |