Duns Number:176528040
Device Description: 2 x 2 25 count box of a non-medicated sterile device in the form of a patch made from wove 2 x 2 25 count box of a non-medicated sterile device in the form of a patch made from woven material (e.g., cotton)
Catalog Number
6202
Brand Name
Green Guard Sterile Gauze Pads
Version/Model Number
6202
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
ba38bb7e-4886-4696-b081-013c7eddfbef
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
June 26, 2019
Package DI Number
50347682620221
Quantity per Package
24
Contains DI Package
00347682620226
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 |