Duns Number:152793493
Device Description: Extra Large Sheer Bandages, 2 in x 4 in Sterile Bandages (50 mm x 100 mm)
Catalog Number
-
Brand Name
Care Band Adhesive Bandages
Version/Model Number
CBD2016
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
6f844594-6f3a-4217-85d1-b737e95d1cb7
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
June 30, 2020
Package DI Number
20017276970306
Quantity per Package
12
Contains DI Package
00017276970302
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 |