FDA UDI
In Commercial Distribution
🇺🇸 United States
Lilly Pulitzer
DI: 00715317840163
·
Model: DUFFRY51
·
Kenmark Optical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lilly Pulitzer
- Primary DI
- 00715317840163
- Version / Model
- DUFFRY51
- Company Name
- Kenmark Optical, Inc.
- Labeler DUNS
- 062952593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-12
- Public Version
- 1
- Public Version Date
- 2021-08-20
- Public Version Status
- New
- Public Device Record Key
- 25e235e7-2129-4b5a-a134-72210c451c99
Device Description
Duffy Ruby Spectacle
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQZ | Frame, spectacle | Ophthalmic | 886.5842 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35065 | Prescription spectacles | An ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00715317840163 | GS1 |
Customer Contacts
- Phone
- +1(502)267-4486 ext. 1138
- [email protected]