Duns Number:116984478
Device Description: Adhesive accessory packs for wearable devices (OMI, ADB); ACCS-1-ST06-1-4
Catalog Number
N/A
Brand Name
BioButton Rechargeable Adhesives
Version/Model Number
ACCS-1-ST06-1-4
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
f5a74b41-9586-4fae-8eb4-4e75433df6d6
Public Version Date
July 04, 2022
Public Version Number
3
DI Record Publish Date
March 01, 2022
Package DI Number
10850005949234
Quantity per Package
50
Contains DI Package
00850005949237
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
50-pack Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |