FDA UDI
In Commercial Distribution
🇺🇸 United States
Lens Exchange Sytem
DI: M687PR104013
·
Model: G25
·
VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- Lens Exchange Sytem
- Primary DI
- M687PR104013
- Version / Model
- G25
- Catalog Number
- PR00104-01
- Company Name
- VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
- Labeler DUNS
- 532007614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2017-06-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1608c2e7-7bc0-4d60-bd37-549e301ef149
Device Description
Lens Exchange System LES G25 three unit package
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KYB | Lens, Guide, Intraocular | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62634 | Intraocular lens implantation cord | A sterile device intended to be attached to, and enable temporary extension of, the haptic loops of an intraocular lens (IOL) to facilitate implantation of the IOL in the posterior chamber of the eye. It typically includes two lengths of cord with connectors and a mounting tray. It is often used during IOL replacement as an alternative to IOL injection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M687PR104013 | HIBCC | ||||
| Unit of Use | M687PR104001 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 43 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store the device in direct sunlight
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – Degrees Celsius