SOFTEC HD PLI SOFTEC HD PLI

GUDID 00844369002301

IOL - HEMA 6.0/13mm (Pre-loaded)

Lenstec Barbados Inc

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00844369002301
• NIH Device Record Key: 523b145c-cdec-4822-a7d5-22cecac08b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFTEC HD PLI
• Version Model Number: SOFHDPLI+11.5D and PLITIP1645 Kit
• Catalog Number: SOFTEC HD PLI
• 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	00844369002301 [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 HD PLI]

• 00844369002875: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002868: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002851: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002844: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002837: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002820: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002813: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002806: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002790: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002783: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002776: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002769: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002752: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002745: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002738: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002721: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002714: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002707: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002691: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002684: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002677: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002660: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002653: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002646: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002639: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002622: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002615: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002608: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002592: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002585: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002578: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002561: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002554: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002547: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002530: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002523: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002516: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002509: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002493: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002486: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002479: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002462: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002455: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002448: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002431: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002424: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002417: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002400: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002394: IOL - HEMA 6.0/13mm (Pre-loaded)
• 00844369002387: IOL - HEMA 6.0/13mm (Pre-loaded)