FDA UDI
In Commercial Distribution
🇺🇸 United States
20D Large Clear, Silver Ring
DI: 00811608010090
·
Model: V20LC-SR
·
VOLK OPTICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 20D Large Clear, Silver Ring
- Primary DI
- 00811608010090
- Version / Model
- V20LC-SR
- Company Name
- VOLK OPTICAL INC.
- Labeler DUNS
- 071125835
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 2
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- c80f0966-8b79-4e26-9adb-2bd43b57fc87
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HJL | Lens, Condensing, Diagnostic | Ophthalmic | 886.1380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47946 | Ophthalmic diagnostic condensing lens | An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811608010090 | GS1 |
Customer Contacts
- Phone
- 440-942-6161
- [email protected]