FDA UDI
In Commercial Distribution
🇺🇸 United States
TRACHEOBRONXANE™ DUMON® RADIOPAQUE
DI: 14063108102413
·
Model: 09051RS
·
NOVATECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRACHEOBRONXANE™ DUMON® RADIOPAQUE
- Primary DI
- 14063108102413
- Version / Model
- 09051RS
- Company Name
- NOVATECH
- Labeler DUNS
- 777211640
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 1
- Public Version Date
- 2024-12-02
- Public Version Status
- New
- Public Device Record Key
- af19c9e0-ca51-4481-9f90-5a9da484d68b
Device Description
Tracheo-bronchial silicone stent, ST 15-13-15 L 15-20-15 ORX
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 Safe
- 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 |
|---|---|---|---|---|
| NWA | Prosthesis, Tracheal, Preformed/Molded | General, Plastic Surgery | 878.3720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46977 | Polymeric tracheal/bronchial stent, non-bioabsorbable | A non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmonary transplantation. It is made entirely of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., semi-soft continuous tube, covered or non-covered mesh structure, straight or branched configuration) intended to conform to the endotracheal/endobronchial surface. It may be expandable in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14063108102413 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243126 | 000 |