FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VisionAir 3D Stent
DI: 00811813020525
·
Model: 0010-0126
·
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VisionAir 3D Stent
- Primary DI
- 00811813020525
- Version / Model
- 0010-0126
- Company Name
- CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
- Labeler DUNS
- 078667390
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 2
- Public Version Date
- 2024-05-02
- Public Version Status
- Update
- Public Device Record Key
- 3124b1a1-007f-4260-b90d-fe908b0f9dc6
- Distribution End Date
- 2024-04-30
Device Description
Patient-Specific Silicone Airway Stent
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | 00811813020525 | GS1 |
Customer Contacts
- Phone
- 2168005905
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight