FDA UDI
In Commercial Distribution
🇺🇸 United States
Multiflex
DI: 00380650701220
·
Model: MTA3U0
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Multiflex
- Primary DI
- 00380650701220
- Version / Model
- MTA3U0
- Catalog Number
- MTA3U0.170
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 5
- Public Version Date
- 2022-01-24
- Public Version Status
- Update
- Public Device Record Key
- ef914fe0-3be0-4076-8509-815216d5cf1e
Device Description
MULTIFLEX(TM*)III SINGLE-PIECE PMMASTERILE ACL (IOL/AC), 12.5mm LENGTH, 5.5mmCONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF.
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
- Yes
- 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 |
|---|---|---|---|---|
| HQL | intraocular lens | Ophthalmic | 886.3600 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35655 | Anterior-chamber intraocular lens, pseudophakic | 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 replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. 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 | 00380650701220 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diopter 17 |