Rael

GUDID 00810027130167

RAEL INC

Menstrual tampon, unscented

• Primary Device ID: 00810027130167
• NIH Device Record Key: 6c4d28e9-215e-454c-9828-0d319b10105b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rael
• Version Model Number: RAEL-TPA-SP-V20-01
• 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: true
• 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	00810027130167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181911

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: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [Rael]

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• 00859306006458: Organic cotton cardboard applicator tampons, super absorbency.
• 00859306006441: Organic cotton cardboard applicator tampons, regular absorbency.
• 00856032008954: Organic cotton cardboard applicator tampons, super absorbency. Distributed in bulk.
• 00856032008947: Organic cotton cardboard applicator tampons, regular absorbency. Distributed in bulk.
• 00810027131614: RAEL-TR-V30-01
• 00810027131621: RAEL-TS-V30-01
• 00810027130709: RAEL-CTS18-V30-01
• 00810027130693: RAEL-CTR18-V30-01
• 00810027130167: RAEL-TPA-SP-V20-01
• 00810027130150: RAEL-TPA-RG-V20-01