SOFTEC I SOFTEC I

GUDID 00844369029407

IOL - HEMA - 1pc 5.75/12.0mm

Lenstec Barbados Inc

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00844369029407
• NIH Device Record Key: 2e3a0973-0e36-4e18-ae7f-9c594e5f1d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFTEC I
• Version Model Number: SOFTECI+19.0
• Catalog Number: SOFTEC I
• Company DUNS: 860235001
• Company Name: Lenstec Barbados 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: true
• 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: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844369029407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090022

FDA Product Code

• HQL: Intraocular Lens

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-01

On-Brand Devices [SOFTEC I]

• 00844369029933: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029926: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029919: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029902: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029896: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029889: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029872: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029865: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029858: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029841: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029827: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029810: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029803: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029797: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029780: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029773: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029766: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029759: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029742: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029735: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029728: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029711: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029704: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029698: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029681: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029674: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029667: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029650: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029643: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029636: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029629: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029612: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029605: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029599: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029582: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029575: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029568: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029551: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029544: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029537: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029520: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029513: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029506: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029490: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029483: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029476: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029469: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029452: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029445: IOL - HEMA - 1pc 5.75/12.0mm
• 00844369029438: IOL - HEMA - 1pc 5.75/12.0mm