Duns Number:086911794
Device Description: A sterile wound cover, gauze pad, intended to be used as an initial, short-term treatment A sterile wound cover, gauze pad, intended to be used as an initial, short-term treatment after an injury. The device is typically used to protect wounds, arrest bleeding, and introduce medications placed on the pad.
Catalog Number
62012
Brand Name
Medi-First Sterile Gauze Pads 2x 2 (10 count)
Version/Model Number
62012
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)
-
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
23a9f5a4-2b9a-4c8e-9097-ddecf43f594f
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
July 12, 2019
Package DI Number
50347682620122
Quantity per Package
24
Contains DI Package
00347682620127
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 | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |