Good Sense Tampons

GUDID 10846036000334

GEISS, DESTIN & DUNN, INC

Menstrual tampon, unscented

• Primary Device ID: 10846036000334
• NIH Device Record Key: bc5d68c8-7ed0-4d0b-9023-0a20a81341f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Good Sense Tampons
• Version Model Number: BGSAR08
• Company DUNS: 076059836
• Company Name: GEISS, DESTIN & DUNN, INC
• Device Count: 8
• 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	00846036000337 [Primary]
GS1	07290016625011 [Unit of Use]
GS1	10846036000334 [Package]; Contains: 00846036000337; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001641

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