OB

GUDID 20078300070102

OB DIG HELIX SUP+ CK 40

EDGEWELL PERSONAL CARE BRANDS, LLC

Menstrual tampon, unscented
Primary Device ID20078300070102
NIH Device Record Keycbafd901-8eb3-4980-b582-e24b9aabfcb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOB
Version Model Number07010
Company DUNS151179769
Company NameEDGEWELL PERSONAL CARE BRANDS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100078300070108 [Primary]
GS100078300141679 [Package]
Contains: 10078300141676
Package: [4 Units]
In Commercial Distribution
GS110078300070105 [Package]
Package: [4 Units]
In Commercial Distribution
GS110078300141676 [Package]
Contains: 00078300070108
Package: [3 Units]
In Commercial Distribution
GS120078300070102 [Package]
Contains: 00078300070108
Package: [3 Units]
In Commercial Distribution

FDA Product Code

HEBTampon, menstrual, unscented

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-09
Device Publish Date2020-04-01

On-Brand Devices [OB]

10078300070211OB DIG PROC SUP BKA 40
10078300070204OB DIG PROC REG GK 40
20078300070157OB DIG PROC MP 40
10078300070143OB DIG PROC SUP BKA 18
10078300070136OB DIG PROC REG GK 18
10078300070129OB DIG HELIX ULTRA DK 40
20078300070119OB DIG HELIX MP 40
20078300070096OB DIG HELIX SUP BK 40
10078300070082OB DIG HELIX REG AL 40
20078300070102OB DIG HELIX SUP+ CK 40
10078300029936OB ORGANIC SUP APLC 18ct 4/3
10078300029868OB ORGANIC REG APLC 18ct 4/3
10078300029851OB ORGANIC SUP NO APLC 24ct 8/3
10078300029837OB ORGANIC REG NO APLC 24ct 8/3
1007830002179440CT o.b. HELIX ULTRA 4/3 (US/CN)

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