FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PolyVue HD Dailies
DI: 08806392000770
·
Model: HD Dailies
·
INTEROJO INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
90
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- PolyVue HD Dailies
- Primary DI
- 08806392000770
- Version / Model
- HD Dailies
- Company Name
- INTEROJO INC.
- Labeler DUNS
- 688455799
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 90
- Record Status
- Published
- Publish Date
- 2019-12-18
- Public Version
- 3
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- aa54373c-33f5-4c4e-b59e-7f4dfdfdb80b
- Distribution End Date
- 2020-01-29
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVN | Lens, Contact, (Disposable) | Ophthalmic | 886.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47841 | Soft corrective contact lens, daily-disposable | A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806392000770 | GS1 | ||||
| Unit of Use | 08806392000787 | GS1 |
Customer Contacts
- Phone
- +1-760-754-2220
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius