Flexlens

GUDID 10847835000167

Flexlens Multifocal

X-Cel Specialty Contacts

Soft corrective contact lens, daily-wear

• Primary Device ID: 10847835000167
• NIH Device Record Key: 884d7a32-2b99-4a51-bdec-0c1efef8876a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexlens
• Version Model Number: Multifocal
• Company DUNS: 048610864
• Company Name: X-Cel Specialty Contacts
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847835000160 [Primary]
GS1	10847835000167 [Package]; Contains: 00847835000160; Package: Carton [3 Units]; In Commercial Distribution
GS1	20847835000164 [Package]; Contains: 00847835000160; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070308

FDA Product Code

• LPL: Lenses, Soft Contact, Daily Wear

Sterilization

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

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

[10847835000167]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-30
• Device Publish Date: 2026-01-22

On-Brand Devices [Flexlens]

• 00847835000009: Flexlens Toric
• 00847835000177: Flexlens Multifocal Vial
• 10847835000167: Flexlens Multifocal
• 00847835000153: Flexlens Adult Aphakic Vial
• 10847835000143: Flexlens Adult Aphakic
• 00847835000139: Flexlens Aphakic Vial
• 10847835000129: Flexlens Aphakic
• 00847835000115: Flexlens PRS Vial
• 10847835000105: Flexlens PRS
• 00847835000092: Flexlens Piggyback Vial
• 10847835000082: Flexlens Piggyback
• 00847835000078: Flexlens Tricurve Keratoconus Vial
• 10847835000068: Flexlens Tricurve Keratoconus
• 00847835000054: Flexlens ARC Vial
• 00847835000047: Flexlens ARC
• 00847835000030: Flexlens Toric Vial
• 00847835000023: Flexlens Sphere Vial
• 10847835000013: Flexlens Sphere