FDA UDI
In Commercial Distribution
🇺🇸 United States
Alcon
DI: 00749590397168
·
Model: 749590397168
·
Alcon Laboratories, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alcon
- Primary DI
- 00749590397168
- Version / Model
- 749590397168
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-19
- Public Version
- 1
- Public Version Date
- 2021-10-27
- Public Version Status
- New
- Public Device Record Key
- 0d3deef7-749b-4b06-86af-945d20dba539
Device Description
Hand-held optical device placed in front of the eyes to aid vision testing.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| HPA | Frame, trial, ophthalmic | Ophthalmic | 886.1415 | 1 |
| HPC | Set, lens, trial, ophthalmic | Ophthalmic | 886.1405 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64350 | Vision testing/training flipper | A device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders. It consists of binocular spherical plus/minus lenses that can quickly be flipped from plus to minus, and which can be used by a healthcare professional for diagnosis or by a patient for self-training. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00749590397168 | GS1 |