MYBOXSHOP

GUDID 00860178002653

Digital Tampons S+

MYBOXSHOP, INC.

Menstrual tampon, unscented

• Primary Device ID: 00860178002653
• NIH Device Record Key: 9fa4c794-41f4-47d5-bb1c-44c2709ddffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYBOXSHOP
• Version Model Number: 860178002653
• Company DUNS: 081229542
• Company Name: MYBOXSHOP, INC.
• Device Count: 16
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002026047 [Unit of Use]
GS1	00860178002653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151170

FDA Product Code

• FRW: Scale, Patient

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-25
• Device Publish Date: 2018-09-11

On-Brand Devices [MYBOXSHOP]

• 00860178002684: Liners
• 00860178002660: Pads day
• 00860178002653: Digital Tampons S+
• 00860178002646: Digital tampons S
• 00860178002639: digital tampons R
• 00860178002622: Applicator tampons R
• 00860178002615: Applicator Tampons S
• 00860178002608: Applicator tampons S+