Duns Number:006961411
Device Description: Advanced Blister Care Adhesive Bandages, 1.33 in x 2.12 in (34 mm x 54 mm)
Catalog Number
-
Brand Name
Equaline
Version/Model Number
041163467491
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
68d147e1-0b94-4b09-95b6-46b4c294bfeb
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
May 29, 2020
Package DI Number
10041163467498
Quantity per Package
24
Contains DI Package
00041163467491
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |