Duns Number:054326178
Device Description: Antiseptic Skin Cleansing Kit with 2% Chlorhexidine Gluconate (CHG)
Catalog Number
9101
Brand Name
Sage
Version/Model Number
9101
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRL
Product Code Name
FIBER, MEDICAL, ABSORBENT
Public Device Record Key
4971ccf5-113e-4f57-a64e-15266f86ea4e
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
December 10, 2018
Package DI Number
50618029850596
Quantity per Package
30
Contains DI Package
00618029850591
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 | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |