SOFTEC HD SOFTEC HD
GUDID 00844369027076
IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear)
Lenstec Barbados Inc
Posterior-chamber intraocular lens, pseudophakic| Primary Device ID | 00844369027076 |
| NIH Device Record Key | 3c3e0281-1230-427d-aec3-32d5e399cd36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOFTEC HD |
| Version Model Number | SOFTECHD+11.0 |
| Catalog Number | SOFTEC HD |
| 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 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| feedback@lenstec.com | |
| Phone | 1-866-536-7832 |
| 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 | 00844369027076 [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]
| 00844369027724 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027717 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027700 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027694 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027687 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027670 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027663 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027656 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027649 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027632 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027625 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027618 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027601 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027595 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027588 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027571 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027564 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027557 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027540 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027533 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027526 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027519 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027502 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027496 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027489 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027472 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027465 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027458 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027441 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027434 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027427 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027410 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027403 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027397 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027380 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027373 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027366 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027359 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027342 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027335 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027328 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027311 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027304 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027298 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027281 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027274 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027267 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027250 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027243 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
| 00844369027236 | IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) |
Trademark Results [SOFTEC HD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTEC HD 85420267 4160410 Live/Registered |
LENSTEC, INC. 2011-09-12 |
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