FDA UDI
In Commercial Distribution
🇺🇸 United States
INGENIX
DI: 00843672100858
·
Model: 55258580
·
INGENIUMSPINE, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INGENIX
- Primary DI
- 00843672100858
- Version / Model
- 55258580
- Company Name
- INGENIUMSPINE, LLC
- Labeler DUNS
- 082805471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-15
- Public Version
- 4
- Public Version Date
- 2024-11-22
- Public Version Status
- Update
- Public Device Record Key
- c4ecd245-6006-40b8-a83c-4b743b00cbb5
Device Description
Iliac screw 8.5x80mm 25 deg
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
- 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
- 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 |
|---|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | 888.3050 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43851 | Gravity-convection laboratory oven | A mains electricity (AC-powered) device used for high-temperature laboratory procedures such as baking, drying, desiccating, and sterilizing, through natural heat convection, items placed within it (e.g., glassware, instruments, cultures, or samples). It operates at temperatures from 5? Celsius above ambient temperature up to 250? Celsius. It is available in a variety of designs and chamber sizes, and the chamber is typically lined with corrosion-proof materials (e.g., stainless steel). The device is thermally insulated, has manual or microprocessor-operated controls, heating elements, and time and temperature sensors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843672100858 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173126 | 000 |