Duns Number:176528040
Device Description: A non-medicated sterile device in the form of a patch made from non-woven material (e.g., A non-medicated sterile device in the form of a patch made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes.
Catalog Number
6215
Brand Name
Green Guard Non-Adherent Pads
Version/Model Number
6215
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
32465795-0703-4ee1-b9e5-535970f3e660
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
June 26, 2019
Package DI Number
50347682062151
Quantity per Package
24
Contains DI Package
00347682062156
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 |