Artisan 206US1W21N
GUDID 08717819060447
Artisan Myopia 5/8.5mm -10.5D
Ophtec B.V.
Anterior-chamber intraocular lens, phakic| Primary Device ID | 08717819060447 |
| NIH Device Record Key | e4297e7d-e32a-476b-9b9c-b843ed06f377 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Artisan |
| Version Model Number | 206US1W |
| Catalog Number | 206US1W21N |
| Company DUNS | 405048120 |
| Company Name | Ophtec B.V. |
| 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 | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.com | |
| Phone | +31505251944 |
| info@ophtec.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 |
| 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 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717819060447 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030028
FDA Product Code
| MTA | Lens, Intraocular, Phakic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2015-08-25 |
On-Brand Devices [Artisan]
| 08717819070323 | Artisan Myopia 6/8.5mm -15.5D |
| 08717819060638 | Artisan Myopia 5/8.5mm -20.0D |
| 08717819060621 | Artisan Myopia 5/8.5mm -19.5D |
| 08717819060614 | Artisan Myopia 5/8.5mm -19.0D |
| 08717819060607 | Artisan Myopia 5/8.5mm -18.5D |
| 08717819060591 | Artisan Myopia 5/8.5mm -18.0D |
| 08717819060584 | Artisan Myopia 5/8.5mm -17.5D |
| 08717819060577 | Artisan Myopia 5/8.5mm -17.0D |
| 08717819060560 | Artisan Myopia 5/8.5mm -16.5D |
| 08717819060553 | Artisan Myopia 5/8.5mm -16.0D |
| 08717819060546 | Artisan Myopia 5/8.5mm -15.5D |
| 08717819060539 | Artisan Myopia 5/8.5mm -15.0D |
| 08717819060522 | Artisan Myopia 5/8.5mm -14.5D |
| 08717819060515 | Artisan Myopia 5/8.5mm -14.0D |
| 08717819060508 | Artisan Myopia 5/8.5mm -13.5D |
| 08717819060492 | Artisan Myopia 5/8.5mm -13.0D |
| 08717819060485 | Artisan Myopia 5/8.5mm -12.5D |
| 08717819060478 | Artisan Myopia 5/8.5mm -12.0D |
| 08717819060461 | Artisan Myopia 5/8.5mm -11.5D |
| 08717819060454 | Artisan Myopia 5/8.5mm -11.0D |
| 08717819060447 | Artisan Myopia 5/8.5mm -10.5D |
| 08717819060430 | Artisan Myopia 5/8.5mm -10.0D |
| 08717819060423 | Artisan Myopia 5/8.5mm -9.5D |
| 08717819060416 | Artisan Myopia 5/8.5mm -9.0D |
| 08717819060409 | Artisan Myopia 5/8.5mm -8.5D |
| 08717819060393 | Artisan Myopia 5/8.5mm -8.0D |
| 08717819060386 | Artisan Myopia 5/8.5mm -7.5D |
| 08717819060379 | Artisan Myopia 5/8.5mm -7.0D |
| 08717819060362 | Artisan Myopia 5/8.5mm -6.5D |
| 08717819060355 | Artisan Myopia 5/8.5mm -6.0D |
| 08717819060348 | Artisan Myopia 5/8.5mm -5.5D |
| 08717819060331 | Artisan Myopia 5/8.5mm -5.0D |
| 08717819060324 | Artisan Myopia 6/8.5mm -15.0D |
| 08717819060317 | Artisan Myopia 6/8.5mm -14.5D |
| 08717819060300 | Artisan Myopia 6/8.5mm -14.0D |
| 08717819060294 | Artisan Myopia 6/8.5mm -13.5D |
| 08717819060287 | Artisan Myopia 6/8.5mm -13.0D |
| 08717819060270 | Artisan Myopia 6/8.5mm -12.5D |
| 08717819060263 | Artisan Myopia 6/8.5mm -12.0D |
| 08717819060256 | Artisan Myopia 6/8.5mm -11.5D |
| 08717819060249 | Artisan Myopia 6/8.5mm -11.0D |
| 08717819060232 | Artisan Myopia 6/8.5mm -10.5D |
| 08717819060225 | Artisan Myopia 6/8.5mm -10.0D |
| 08717819060218 | Artisan Myopia 6/8.5mm -9.5D |
| 08717819060201 | Artisan Myopia 6/8.5mm -9.0D |
| 08717819060195 | Artisan Myopia 6/8.5mm -8.5D |
| 08717819060188 | Artisan Myopia 6/8.5mm -8.0D |
| 08717819060171 | Artisan Myopia 6/8.5mm -7.5D |
| 08717819060164 | Artisan Myopia 6/8.5mm -7.0D |
| 08717819060157 | Artisan Myopia 6/8.5mm -6.5D |
Trademark Results [Artisan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTISAN 98304112 not registered Live/Pending |
MatOrtho Limited 2023-12-07 |
 ARTISAN 97623555 not registered Live/Pending |
L'Chef, LLC 2022-10-07 |
 ARTISAN 97428868 not registered Live/Pending |
Shenzhen Snapmaker Technologies Co., Ltd. 2022-05-25 |
 ARTISAN 97428850 not registered Live/Pending |
Shenzhen Snapmaker Technologies Co., Ltd. 2022-05-25 |
 ARTISAN 97428835 not registered Live/Pending |
Shenzhen Snapmaker Technologies Co., Ltd. 2022-05-25 |
 ARTISAN 97424543 not registered Live/Pending |
Idea Nuova, Inc. 2022-05-23 |
 ARTISAN 90647154 not registered Live/Pending |
Aquavit Pharmaceuticals, Inc. 2021-04-15 |
 ARTISAN 90593146 not registered Live/Pending |
Artisan Industries, Inc. 2021-03-22 |
 ARTISAN 90420529 not registered Live/Pending |
The Yeast Bay 2020-12-28 |
 ARTISAN 90406579 not registered Live/Pending |
Shenzhen Snapmaker Technologies Co., Ltd. 2020-12-23 |
 ARTISAN 90241968 not registered Live/Pending |
Gjoraas, Joshua 2020-10-08 |
 ARTISAN 90233035 not registered Live/Pending |
Artisan Enterprises, LLC 2020-10-02 |
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