Premier Tampons

GUDID 07290016625516

Premier Bulk Tampons - 520 CBD Regular

AL-BAD MASSUOT YITZHAK LTD

Menstrual tampon, unscented

• Primary Device ID: 07290016625516
• NIH Device Record Key: 10850659-3da2-44a6-998a-b7b284eb2847
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Tampons
• Version Model Number: PRARBK520
• Company DUNS: 600487813
• Company Name: AL-BAD MASSUOT YITZHAK LTD
• Device Count: 520
• 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	07290016625011 [Unit of Use]
GS1	07290016625516 [Primary]

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 [Premier Tampons]

• 07290016625523: Premier Bulk Tampons - 520 CBD Super
• 07290016625516: Premier Bulk Tampons - 520 CBD Regular