Rael Organic Cotton Tampons: Regular Absorbancy

GUDID 00856032008442

A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.

RAEL INC

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• Primary Device ID: 00856032008442
• NIH Device Record Key: 95fe24ff-2efa-4fc6-9a4b-82418314a26f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rael Organic Cotton Tampons: Regular Absorbancy
• Version Model Number: RAEL-TP-RG-01
• Company DUNS: 087378348
• Company Name: RAEL INC
• Device Count: 1
• 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	00856032008442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182814

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: 2019-08-28
• Device Publish Date: 2019-08-20

Devices Manufactured by RAEL INC

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• 00856032008442 - Rael Organic Cotton Tampons: Regular Absorbancy: 2019-08-28A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
• 00856032008442 - Rael Organic Cotton Tampons: Regular Absorbancy: 2019-08-28 A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an appli
• 00856032008947 - RAEL: 2019-05-27 Organic cotton cardboard applicator tampons, regular absorbency. Distributed in bulk.