Duns Number:176528040
Device Description: A small, narrow piece of flexible material covered on one side with a pressure-sensitive a A small, narrow piece of flexible material covered on one side with a pressure-sensitive adhesive, and with broad, wing-shaped ends that function to approximate the edges of a superficial wound.
Catalog Number
6397
Brand Name
Green Guard Butterfly Closure
Version/Model Number
6397
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
cbc2f248-7cef-46db-a091-45f4329f867a
Public Version Date
July 04, 2019
Public Version Number
1
DI Record Publish Date
June 26, 2019
Package DI Number
50347682063974
Quantity per Package
24
Contains DI Package
00347682063979
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 |