FDA UDI
In Commercial Distribution
🇺🇸 United States
TruDi NAVWIRE
DI: 10705031245907
·
Model: TDNW001
·
ACCLARENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TruDi NAVWIRE
- Primary DI
- 10705031245907
- Version / Model
- TDNW001
- Catalog Number
- TDNW001
- Company Name
- ACCLARENT, INC.
- Labeler DUNS
- 361092450
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-20
- Public Version
- 2
- Public Version Date
- 2020-01-22
- Public Version Status
- Update
- Public Device Record Key
- 41ee40d1-cdf3-4413-8342-ff2216991d51
Device Description
TruDi NAVWIRE Sinus Navigation Guidewire - 5PK
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PGW | Ear, Nose, and Throat Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48145 | Paranasal sinus guidewire | A sterile device intended to be used to provide a means to access the paranasal sinuses for diagnostic and therapeutic procedures (e.g., sinuplasty). It is made of stiff but bendable material, typically with a preshaped radiopaque distal tip and a lubricious coating to enable precise steering to navigate the anatomy of the sinuses. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705031245904 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 10705031245907 | GS1 |
Customer Contacts
- Phone
- +1(650)687-5888
- [email protected]
- Phone
- +1(877)775-2789
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190532 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place