Dong-A Pharmaceutical Co., Ltd.

GUDID 08806011633242

The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Dong-A Pharmaceutical Co., Ltd.

Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented
Primary Device ID08806011633242
NIH Device Record Key937923cd-8c1e-44d2-982a-2aa779eb0732
Commercial Distribution StatusIn Commercial Distribution
Brand NameDong-A Pharmaceutical Co., Ltd.
Version Model NumberTempo Tampon Super
Company DUNS688733015
Company NameDong-A Pharmaceutical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
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
GS108806011633242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-02-22
Device Publish Date2023-02-14

On-Brand Devices [Dong-A Pharmaceutical Co., Ltd. ]

08806011635703The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstru
08806011635697The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstru
08806011633242The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or ot
08806011632863The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or ot
08806011816621FATION NOSCA9 SPOT PATCH
08806011637462Tempo Natural Cotton Overnight Super Long
08806011637097Tempo Natural Cotton Pad - L
08806011637080Tempo Natural Cotton Pad - M
08806011636755Tempo Natural Cotton Liner Long

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