Elite

GUDID 00850057194111

Electrology Hair Removal (Needle Epilation)

Clareblend, Inc.

Professional hair-removal electrolysis system

• Primary Device ID: 00850057194111
• NIH Device Record Key: 96f8b5c2-57c6-4ddf-8059-afe21030f6d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite
• Version Model Number: 2022-EL
• Company DUNS: 139701114
• Company Name: Clareblend, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850057194111 [Primary]

FDA Product Code

• KCW: EPILATOR, HIGH FREQUENCY, NEEDLE-TYPE

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: 2023-12-22
• Device Publish Date: 2023-12-14

Devices Manufactured by Clareblend, Inc.

• 00850057194005 - Elegance+: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194036 - Elegance: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194043 - G-Tech: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194050 - Essence: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194067 - EZ3: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194074 - Lamprobe: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194081 - Skin Classic: 2023-12-22 Electrology Hair Removal (Needle Epilation)
• 00850057194098 - Thermoclear: 2023-12-22 Electrology Hair Removal (Needle Epilation)