PVS SOFTOK SiHy/1Day/30PK

GUDID 00840486901541

Sihy/UV/60T/PWR: -11.50

VIZIONFOCUS INC.

Soft corrective contact lens, daily-disposable

• Primary Device ID: 00840486901541
• NIH Device Record Key: 470db2c5-c8a7-43fa-a76e-7671def98d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PVS SOFTOK SiHy/1Day/30PK
• Version Model Number: 9M41
• Company DUNS: 658860374
• Company Name: VIZIONFOCUS 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: true
• 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	00840486901541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242413

FDA Product Code

• LPL: Lenses, Soft Contact, Daily Wear

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23

On-Brand Devices [PVS SOFTOK SiHy/1Day/30PK]

• 00840486901596: Sihy/UV/60T/PWR: -14.00
• 00840486901589: Sihy/UV/60T/PWR: -13.50
• 00840486901572: Sihy/UV/60T/PWR: -13.00
• 00840486901565: Sihy/UV/60T/PWR: -12.50
• 00840486901558: Sihy/UV/60T/PWR: -12.00
• 00840486901541: Sihy/UV/60T/PWR: -11.50
• 00840486901534: Sihy/UV/60T/PWR: -11.00
• 00840486901527: Sihy/UV/60T/PWR: -10.50
• 00840486901510: Sihy/UV/60T/PWR: -10.00
• 00840486901503: Sihy/UV/60T/PWR: -9.50
• 00840486901497: Sihy/UV/60T/PWR: -9.00
• 00840486901480: Sihy/UV/60T/PWR: -8.50
• 00840486901473: Sihy/UV/60T/PWR: -8.00
• 00840486901466: Sihy/UV/60T/PWR: -7.50
• 00840486901459: Sihy/UV/60T/PWR: -7.00
• 00840486901442: Sihy/UV/60T/PWR: -6.50
• 00840486901435: Sihy/UV/60T/PWR: -6.00
• 00840486901411: Sihy/UV/60T/PWR: -5.50
• 00840486901398: Sihy/UV/60T/PWR: -5.00
• 00840486901374: Sihy/UV/60T/PWR: -4.50
• 00840486901350: Sihy/UV/60T/PWR: -4.00
• 00840486901336: Sihy/UV/60T/PWR: -3.50
• 00840486901312: Sihy/UV/60T/PWR: -3.00
• 00840486901299: Sihy/UV/60T/PWR: -2.50
• 00840486901275: Sihy/UV/60T/PWR: -2.00
• 00840486901251: Sihy/UV/60T/PWR: -1.50
• 00840486901237: Sihy/UV/60T/PWR: -1.00
• 00840486901213: Sihy/UV/60T/PWR: -0.50