Duns Number:007941230
Device Description: Gauze Sponge Sterile 10/Tray 4 Inch X 4 Inch 12-Ply 100% Cotton Hypoallergenic Single Use Gauze Sponge Sterile 10/Tray 4 Inch X 4 Inch 12-Ply 100% Cotton Hypoallergenic Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
GZ4008
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)
-
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
33e016c0-e3a1-44c4-aa8a-698e4f4acc4b
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
September 17, 2020
Package DI Number
20885632069632
Quantity per Package
128
Contains DI Package
10885632069635
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |