Duns Number:152793493
Device Description: Antibacterial Bandages, assorted shapes & Sizes, 3/4" strips, .75 IN x 3 IN (19 mm x 76 mm Antibacterial Bandages, assorted shapes & Sizes, 3/4" strips, .75 IN x 3 IN (19 mm x 76 mm), 5/8" strips, .62 IN x 2.25 IN (15 mm x 57 mm), circles, 1.25 IN x 1.25 IN (31 mm x 31 mm)
Catalog Number
-
Brand Name
Sonic The Hedgehog
Version/Model Number
017276239096
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)
Yes
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
7f0812af-117d-45bb-abea-eca08ce665a9
Public Version Date
September 05, 2022
Public Version Number
1
DI Record Publish Date
August 26, 2022
Package DI Number
20017276239090
Quantity per Package
72
Contains DI Package
00017276239096
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |