Body Form tampons

GUDID 10659205263085

AL-BAD MASSUOT YITZHAK LTD

Menstrual tampon, unscented

• Primary Device ID: 10659205263085
• NIH Device Record Key: 348a4a3f-0341-4971-9dd1-f0b528f8fc32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Form tampons
• Version Model Number: BBFAS08
• Company DUNS: 600487813
• Company Name: AL-BAD MASSUOT YITZHAK LTD
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00659205263088 [Primary]
GS1	07290016625028 [Unit of Use]
GS1	10659205263085 [Package]; Contains: 00659205263088; Package: CASE [24 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: 2016-10-31

On-Brand Devices [Body Form tampons]

• 10659205264082: BBFAP08-0
• 10659205263085: BBFAS08
• 10659205262088: BBFAR08