FDA UDI
In Commercial Distribution
🇺🇸 United States
Elastimide UV-Absorbing Silicone Posterior Chamber Intraocular Lens
DI: 00841542100366
·
Model: AQ2010V
·
STAAR SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elastimide UV-Absorbing Silicone Posterior Chamber Intraocular Lens
- Primary DI
- 00841542100366
- Version / Model
- AQ2010V
- Company Name
- STAAR SURGICAL COMPANY
- Labeler DUNS
- 054751110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-20
- Public Version
- 4
- Public Version Date
- 2021-07-08
- Public Version Status
- Update
- Public Device Record Key
- a06e6505-ee0d-4789-963a-71820ca85ba3
Device Description
Diopter: 27.0 Three Piece
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 |
|---|---|---|---|---|
| HQL | Intraocular Lens | Ophthalmic | 886.3600 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35658 | Posterior-chamber intraocular lens, pseudophakic | An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. 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 | 00841542100366 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P880091 | 000 |