FDA UDI
In Commercial Distribution
🇺🇸 United States
Artisan
DI: 08717819060232
·
Model: 204US1W
·
Ophtec B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Artisan
- Primary DI
- 08717819060232
- Version / Model
- 204US1W
- Catalog Number
- 204US1W21N
- Company Name
- Ophtec B.V.
- Labeler DUNS
- 405048120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-25
- Public Version
- 6
- Public Version Date
- 2021-08-30
- Public Version Status
- Update
- Public Device Record Key
- 7c283bed-c01e-422f-ac58-1e8872855bff
Device Description
Artisan Myopia 6/8.5mm -10.5D
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MTA | Lens, Intraocular, Phakic | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47410 | Anterior-chamber intraocular lens, phakic | An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the region of the eye posterior of the cornea and anterior of the iris (anterior chamber) to provide refractive correction of vision without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; disposable devices associated with implantation (e.g., IOL injector) may be included with the lens. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717819060232 | GS1 |
Customer Contacts
- Phone
- +31505251944
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030028 | 001 |
| P030028 | 002 |
| P030028 | 003 |
| P030028 | 004 |
| P030028 | 005 |
| P030028 | 006 |
| P030028 | 008 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | -10.5 Power, D |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 40 Degrees Celsius