FDA UDI
In Commercial Distribution
🇺🇸 United States
Lombart
DI: 00628308210527
·
Model: RT-600-LP-BLK
·
INNOVA Medical Ophthalmics Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lombart
- Primary DI
- 00628308210527
- Version / Model
- RT-600-LP-BLK
- Company Name
- INNOVA Medical Ophthalmics Inc
- Labeler DUNS
- 243325332
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-31
- Public Version
- 1
- Public Version Date
- 2026-04-08
- Public Version Status
- New
- Public Device Record Key
- e23d344c-4b4f-49a7-a9d9-ce8bb352d22f
Device Description
Lombart Black +CYL refractor
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
- 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 |
|---|---|---|---|---|
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | Ophthalmic | 886.1770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66911 | Phoropter, manual | A manually-operated ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as a manual refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist manually changes the lenses and other settings while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628308210527 | GS1 |