FDA UDI
In Commercial Distribution
🇺🇸 United States
VERION™
DI: 00380659982682
·
Model: 8065998268
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VERION™
- Primary DI
- 00380659982682
- Version / Model
- 8065998268
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 1
- Public Version Date
- 2020-09-08
- Public Version Status
- New
- Public Device Record Key
- 5917b9fd-7239-4799-86b8-974c646dd2f7
Device Description
VERION™ Reference Unit
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFG | Device, communications, images, ophthalmic | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12811 | Bench-top keratometer | A bench-top, mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380659982682 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]