INTCO

GUDID B845TPVPEBR23

Intco Medical Industries, Inc.

Menstrual tampon, unscented

• Primary Device ID: B845TPVPEBR23
• NIH Device Record Key: baa67b5b-3494-4dff-bd8b-965d03f6e896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTCO
• Version Model Number: TPVPEB-R2
• Company DUNS: 080162537
• Company Name: Intco Medical Industries, Inc.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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
HIBCC	B845TPVPEBR2 [Unit of Use]
HIBCC	B845TPVPEBR21 [Primary]
HIBCC	B845TPVPEBR23 [Package]; Contains: B845TPVPEBR21; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190218
• Premarket Notification: K192557

FDA Product Code

• HEB: Tampon, Menstrual, Unscented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [INTCO]

• B845TPVPEBR23: TPVPEB-R2
• B845TPVPEBS21: TPVPEB-S2