SGP II

GUDID 00830002002012

Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, Brown, Gray, or Clear Number of Units

LIFESTYLE CO INC, THE

Rigid-gas-permeable corrective contact lens, daily-wear

• Primary Device ID: 00830002002012
• NIH Device Record Key: 38c68841-4d30-40be-ab18-0ae2e54a54b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SGP II
• Version Model Number: telefocon B
• Company DUNS: 946065000
• Company Name: LIFESTYLE CO INC, THE
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8006220777
• Email: lenses@lifestylecompany.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00830002002012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840055

FDA Product Code

• HQD: Lens, Contact (Other Material) - Daily

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-24

Devices Manufactured by LIFESTYLE CO INC, THE

• 00830002000087 - PuriLens Plus Preservative Free Saline: 2021-10-04 PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with
• 00830002000032 - PuriLens Plus Disinfecting System Lens Basket: 2021-10-04 Replacement lens basket packaged in plastic zip-lock bag.
• 00830002000049 - PuriLens Plus Disinfecting System Cleaning Chamber: 2021-10-04 Replacement cleaning chamber packaged in plastic zip-lock bag.
• 00830002000056 - PuriLens Plus Disinfecting System Exchange Kit: 2021-10-04 Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
• 00830002000063 - PuriLens Plus Disinfecting System: 2021-10-04 Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinfecting chamber, two 4-oz. (120-mL) bot
• 00830002000070 - PuriLens Plus Disinfecting System 110V Adapter: 2021-10-04 Replacement 110V Adapter packaged in plastic zip-lock bag.
• 00830002000094 - PuriLens Plus Preservative Free Saline: 2021-10-04 PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with
• 00830002001015 - SGP: 2018-07-06 Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, Brown, or Gray Number of Units