Duns Number:932938897
Device Description: Sterile Cotton Balls (130ct Medium Size)
Catalog Number
-
Brand Name
Publix
Version/Model Number
B FMDLS 0130 R02401 PB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2022
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
FRL
Product Code Name
Fiber, Medical, Absorbent
Public Device Record Key
c43d66ca-b721-4e9d-be25-ed77b4f639a8
Public Version Date
August 16, 2022
Public Version Number
2
DI Record Publish Date
February 28, 2020
Package DI Number
20041415009688
Quantity per Package
24
Contains DI Package
00041415009684
Package Discontinue Date
March 01, 2022
Package Status
Not 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 | 7 |