FDA UDI
In Commercial Distribution
🇺🇸 United States
TrueTear
DI: 00850102007182
·
Model: F-0050
·
OCULEVE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
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Basic Information
- Brand Name
- TrueTear
- Primary DI
- 00850102007182
- Version / Model
- F-0050
- Catalog Number
- F-0050
- Company Name
- OCULEVE, INC.
- Labeler DUNS
- 078797682
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2018-02-15
- Public Version
- 4
- Public Version Date
- 2021-05-24
- Public Version Status
- Update
- Public Device Record Key
- 3ec3292c-14c6-44d4-b9cc-6736af1b6ffd
Device Description
TrueTear Gen 1.5 Disposable Tip
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQJ | Intranasal electrostimulation device | Ophthalmic | 886.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62549 | Intranasal lacrimal electrical neurostimulator electrode | An electrical conductor designed to be attached to a hand-held intranasal lacrimal neurostimulator to deliver electrical stimuli to sensory neurons of the nasal cavities to acutely increase tear production as treatment for aqueous deficient dry eye. It is a double-pronged device, made of metal and synthetic polymer materials (e.g., hydrogel), intended to be inserted into the nostrils. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850102007182 | GS1 | ||||
| Unit of Use | 10850102007189 | GS1 |
Customer Contacts
- Phone
- +1(415)745-3784
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN160030 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius