Duns Number:176528040
Device Description: A large non-medicated sterile device in the form of a patch made from woven cotton materia A large non-medicated sterile device in the form of a patch made from woven cotton material.
Catalog Number
6520
Brand Name
Green Guard Emergancy Large Wound Dressing
Version/Model Number
6520
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
1e7438f9-8532-4d73-934d-d7687ee22b2f
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
June 26, 2019
Package DI Number
50347682065206
Quantity per Package
24
Contains DI Package
00347682065201
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 |