Duns Number:679894738
Device Description: Sponge prep stick_blue sponge and white prep stick_bulk packaged_1000ea/cs
Catalog Number
-
Brand Name
B.braun
Version/Model Number
Model A7401105
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXF
Product Code Name
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Public Device Record Key
e8ebd8b0-252e-4a95-b878-ce86a8675837
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 27, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 185 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 295 |