Duns Number:117588619
Device Description: Ultra Thin Panty Liner; individually wrapped, organic cotton top sheet
Catalog Number
LBOUN001
Brand Name
2XChromosome
Version/Model Number
(2X)200920PL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
HHD
Product Code Name
Pad, Menstrual, Unscented
Public Device Record Key
1165494b-c57b-402a-8ab5-d223cedbf40b
Public Version Date
August 01, 2022
Public Version Number
2
DI Record Publish Date
April 30, 2021
Package DI Number
10850022610018
Quantity per Package
48
Contains DI Package
00850022610011
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
-