Kradsale Tampons

GUDID 10075130803644

AL-BAD MASSUOT YITZHAK LTD

Menstrual tampon, unscented

• Primary Device ID: 10075130803644
• NIH Device Record Key: 64a4cd2e-3f57-4835-b469-36f33a560d73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kradsale Tampons
• Version Model Number: BKRGS18
• Company DUNS: 600487813
• Company Name: AL-BAD MASSUOT YITZHAK LTD
• 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	00075130803647 [Primary]
GS1	07290016625127 [Unit of Use]
GS1	10075130803644 [Package]; Contains: 00075130803647; 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: 2016-11-06

On-Brand Devices [Kradsale Tampons]

• 10075130803644: BKRGS18
• 10075130803637: BKRGR20
• 10075130803620: BKRAS20
• 10075130803613: BKRAR20
• 10075130803583: Multi pack Box of 36 tampons, 8 light, 20 regular, and 8 super absorbency