FDA UDI
In Commercial Distribution
🇺🇸 United States
Irix-A Lumbar Integrated Fusion System
DI: M697X08000071
·
Model: X080-0007
·
Xtant Medical Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Irix-A Lumbar Integrated Fusion System
- Primary DI
- M697X08000071
- Version / Model
- X080-0007
- Company Name
- Xtant Medical Holdings, Inc.
- Labeler DUNS
- 081224143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-30
- Public Version
- 5
- Public Version Date
- 2024-11-18
- Public Version Status
- Update
- Public Device Record Key
- 6988acfe-8152-4a2d-90ab-c9624c08aed3
Device Description
Irix A Sterlization Case, Anterior Lumbar Disc Prep
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LRP | TRAY, SURGICAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | M697X08000070 | HIBCC | ||||
| Primary | M697X08000071 | HIBCC |
Customer Contacts
- Phone
- +1(888)886-9354
- [email protected]