Duns Number:152793493
Device Description: Waterproof Adhesive Bandages, assorted sizes, 3/4 IN x 1 1/2 IN (19 mm x 38 mm); 3/4 IN x Waterproof Adhesive Bandages, assorted sizes, 3/4 IN x 1 1/2 IN (19 mm x 38 mm); 3/4 IN x 2 IN (19 mm x 50 mm); 1 IN x 2 1/2 IN (25 mm x 63 mm)
Catalog Number
-
Brand Name
Sound Body
Version/Model Number
481042591105
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
55a5cf2a-5570-488c-9a02-37d4f203d739
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 27, 2020
Package DI Number
20481042591109
Quantity per Package
72
Contains DI Package
00481042591105
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 |