Duns Number:068586441
Device Description: Applicator Cotton Tip Sterile 6" Wood 2's, 100/Bx
Catalog Number
782050
Brand Name
Dealmed
Version/Model Number
782050
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
KXG
Product Code Name
APPLICATOR, ABSORBENT TIPPED, STERILE
Public Device Record Key
d9a3d713-2f2d-4df4-865d-370ca4791ada
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
November 12, 2020
Package DI Number
00817415020185
Quantity per Package
10
Contains DI Package
00817415020178
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |