FDA UDI
In Commercial Distribution
🇺🇸 United States
Companion Spine DIAM™ Instrumentation
DI: 03701521300415
·
Model: DIAM™ Spinal Stabilization System, Outer Case (alt. Inserter)
·
COMPANION SPINE FRANCE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Companion Spine DIAM™ Instrumentation
- Primary DI
- 03701521300415
- Version / Model
- DIAM™ Spinal Stabilization System, Outer Case (alt. Inserter)
- Catalog Number
- CS001C0035
- Company Name
- COMPANION SPINE FRANCE
- Labeler DUNS
- 275237939
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 1
- Public Version Date
- 2026-01-20
- Public Version Status
- New
- Public Device Record Key
- 91dcdaac-1d34-4aa9-8731-52283c3468a6
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
- Yes
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47127 | Lumbar interspinous decompression instrument set, reusable | A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701521300415 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253118 | 000 |