SOFTEC HDM SOFTEC HDM

GUDID 00844369039079

IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)

Lenstec Barbados Inc

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00844369039079
• NIH Device Record Key: 9695b1b5-90af-49b4-83e8-ad1410e1731b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFTEC HDM
• Version Model Number: SOFTECHDM+13.5
• Catalog Number: SOFTEC HDM
• 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	00844369039079 [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: 2016-09-23

On-Brand Devices [SOFTEC HDM]

• 00844369039727: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039710: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039703: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039697: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039680: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039666: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039659: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039642: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039635: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039628: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039611: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039604: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039598: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039581: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039574: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039567: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039550: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039543: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039536: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039529: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039512: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039505: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039499: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039482: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039475: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039468: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039451: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039444: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039437: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039420: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039413: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039406: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039390: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039383: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039376: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039369: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039352: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039345: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039338: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039321: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039314: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039307: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039291: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039284: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039277: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039260: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039253: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039246: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039239: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
• 00844369039222: IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)