Good Sense Tampons

GUDID 00846036004083

GEISS, DESTIN & DUNN, INC

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 ID	00846036004083
NIH Device Record Key	b1508805-a236-403b-81fe-fbe04e948a0f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Good Sense Tampons
Version Model Number	BGSGS18
Company DUNS	076059836
Company Name	GEISS, DESTIN & DUNN, INC
Device Count	18
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846036004083 [Primary]
GS1	07290016625127 [Unit of Use]
GS1	10846036004080 [Package] Package: CASE [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042773

FDA Product Code

HEB	Tampon, Menstrual, Unscented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-09
Device Publish Date	2016-09-20

On-Brand Devices [Good Sense Tampons]

00846036004083	BGSGS18
10846036003168	BGSGR20
10846036000334	BGSAR08
10846036000181	BGSAS20