Rael

GUDID 00810027130709

RAEL INC

Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented

• Primary Device ID: 00810027130709
• NIH Device Record Key: 739869b6-9a92-4d74-963a-f4b89db4f6d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rael
• Version Model Number: RAEL-CTS18-V30-01
• 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	00810027130709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191431

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]

• 00859306006472: Organic cotton non-applicator tampons, super absorbency.
• 00859306006465: Organic cotton non-applicator tampons, regular absorbency.
• 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