FDA UDI
In Commercial Distribution
🇺🇸 United States
M6-C
DI: 00812388032616
·
Model: PK 0329
·
Spinal Kinetics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- M6-C
- Primary DI
- 00812388032616
- Version / Model
- PK 0329
- Catalog Number
- CIT-400-08
- Company Name
- Spinal Kinetics, Inc.
- Labeler DUNS
- 171513125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 1
- Public Version Date
- 2024-09-17
- Public Version Status
- New
- Public Device Record Key
- 02c1f92f-a195-4e48-bc1f-802e214ce133
Device Description
M6-C Instrument Preparation Tray
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
- 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 |
|---|---|---|---|---|
| QLQ | Manual Instruments Designed For Total Disc Replacement Device | Orthopedic | 888.4515 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44054 | Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812388032616 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241117 | 000 |