Duns Number:080935429
Device Description: Calcium Alginate Dressing,Rope
Catalog Number
9243
Brand Name
Kendall
Version/Model Number
9243
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
KMF
Product Code Name
Bandage, liquid
Public Device Record Key
34880002-1e9f-47a1-8491-00c4acafce86
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
June 27, 2018
Package DI Number
40884521025012
Quantity per Package
20
Contains DI Package
10884521025011
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 |