Duns Number:080935429
Device Description: Foam Border Gentle Adhesion,2 Inch x 2 Inch (5.1 cm x 5.1 cm) Pad
Catalog Number
55544BG
Brand Name
Kendall
Version/Model Number
55544BG
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)
-
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
5b519a7b-68d7-4c39-8f28-1d91fb9b9f5c
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
June 27, 2018
Package DI Number
00884521166908
Quantity per Package
50
Contains DI Package
00884521166861
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |