Duns Number:080349866
Device Description: Sheer Adhesive Bandages, assorted, 2 in x 4 in (50 mm x 101 mm); 1 in x 3 in (25 mm x 76 m Sheer Adhesive Bandages, assorted, 2 in x 4 in (50 mm x 101 mm); 1 in x 3 in (25 mm x 76 mm); 3/4 in x 3 in (19 mm x 76 mm); 5/8 in x 2 1/4 in (15 mm x 57 mm); 7/8 in x 7/8 in (22 mm x 22 mm)
Catalog Number
-
Brand Name
Signature Care
Version/Model Number
321130795650
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2020
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
79719761-9423-4c53-a3ba-b673c0f74f3b
Public Version Date
August 27, 2021
Public Version Number
2
DI Record Publish Date
July 31, 2020
Package DI Number
10321130795657
Quantity per Package
72
Contains DI Package
00321130795650
Package Discontinue Date
October 02, 2020
Package Status
Not 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |