SOFTEC HDO SOFTEC HDO

GUDID 00844369037419

IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)

Lenstec Barbados Inc

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00844369037419
• NIH Device Record Key: f195f155-4a5f-4353-a9cd-2b72e8034871
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFTEC HDO
• Version Model Number: SOFTECHDO+21.5
• Catalog Number: SOFTEC HDO
• 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	00844369037419 [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 HDO]

• 00844369037716: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037709: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037693: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037686: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037679: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037662: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037655: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037648: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037631: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037624: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037617: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037600: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037594: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037587: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037570: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037563: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037556: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037549: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037532: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037525: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037518: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037501: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037495: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037488: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037471: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037464: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037457: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037440: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037433: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037426: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037419: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037402: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037396: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037389: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037372: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037365: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037358: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037341: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037334: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037327: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037310: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037303: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037297: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037280: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037273: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037266: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037259: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037242: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037235: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)
• 00844369037228: IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear)