FDA UDI
In Commercial Distribution
🇺🇸 United States
Longeviti Convenience Kit 5.0
DI: 00855113008661
·
Model: 700075
·
LONGEVITI NEURO SOLUTIONS LLC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Longeviti Convenience Kit 5.0
- Primary DI
- 00855113008661
- Version / Model
- 700075
- Company Name
- LONGEVITI NEURO SOLUTIONS LLC
- Labeler DUNS
- 070659539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-15
- Public Version
- 2
- Public Version Date
- 2024-04-12
- Public Version Status
- Update
- Public Device Record Key
- ea128170-5829-4975-bae0-c70435c29d23
Device Description
ClearFit & InvisiShunt Conveniece Kit
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
- Yes
- 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 |
|---|---|---|---|---|
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | General, Plastic Surgery | 878.3500 | 2 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Microbiology | 866.3330 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16131 | Cranial resinous compound | A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused. | Yes | Active |
| 33310 | Polyethylene craniofacial tissue reconstructive material | A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855113008661 | GS1 |