Shopko Tampons

GUDID 10400265047463

Shopko

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 ID: 10400265047463
• NIH Device Record Key: 38a8c736-dd4a-4bd6-b2be-e6c1b3718274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shopko Tampons
• Version Model Number: BSKGS36
• Company DUNS: 023252638
• Company Name: Shopko
• Device Count: 36
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00400265047466 [Primary]
GS1	07290016625127 [Unit of Use]
GS1	10400265047463 [Package]; Contains: 00400265047466; 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: 2017-10-02

On-Brand Devices [Shopko Tampons]

• 10400265047531: BSKGS18
• 10400265047463: BSKGS36
• 10400265047388: BSKGR36
• 10400265047203: BSKPP34
• 10400265047128: Multipack of 34 plastic applicator tampons, 17 regular and 17 super absorbency
• 00400265047046: BSKUS18
• 10400265046961: BSKUR18
• 10400131052591: BSKGS18
• 10400131052263: BSKGR20