FDA UDI
In Commercial Distribution
🇺🇸 United States
ACRYSOF® IQ RESTOR®
DI: 00380659909481
·
Model: Version 1
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ACRYSOF® IQ RESTOR®
- Primary DI
- 00380659909481
- Version / Model
- Version 1
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-20
- Public Version
- 5
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 13166963-43e6-49d5-888d-0a3714fdfb9f
Device Description
AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MFK | LENS, MULTIFOCAL INTRAOCULAR | Ophthalmic | 886.3600 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52847 | Intraocular lens calculation software | A stand-alone software application designed to assist a surgeon in the selection and placement of an intraocular lens (IOL) by performing calculations to help predict the amount of postoperative corneal astigmatism that needs to be corrected. It is designed to be installed on an off-the-shelf computer/smart device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380659909481 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]