FDA UDI
In Commercial Distribution
🇺🇸 United States
iTrack Advance
DI: 00893872001622
·
Model: iTrack-ADS
·
Nova Eye, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iTrack Advance
- Primary DI
- 00893872001622
- Version / Model
- iTrack-ADS
- Catalog Number
- 203000-0001
- Company Name
- Nova Eye, Inc.
- Labeler DUNS
- 079755637
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-04
- Public Version
- 1
- Public Version Date
- 2023-04-12
- Public Version Status
- New
- Public Device Record Key
- a5a37df0-492a-4c0d-8056-e1f72ce026e2
Device Description
Canaloplasty Microcatheter Kit with Advanced Delivery System Kit Contents (1) Canaloplasty Microcatheter with Delivery System (2) Ophthalmic ViscoInjector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
| MPA | Endoilluminator | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42572 | Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use | A hand-held ophthalmic surgical instrument with a thin, rigid insertion portion designed to infuse, irrigate and/or aspirate the interior of the eye during a surgical procedure (e.g., cataract extraction), and simultaneously conduct, typically via a fibreoptic bundle, a field of cold light to illuminate the surgical site. It is connected to a light source (through a light cable) and to appropriate devices that provide the infusion/aspiration function. It is typically made of high-grade stainless steel and fibreoptic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893872001622 | GS1 |
Customer Contacts
- Phone
- 1-510-291-1300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221872 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 45 | Millimeter | |
| Outer Diameter | 250 | Micrometer |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry location at room temperature