FDA UDI
In Commercial Distribution
🇺🇸 United States
Minuteman
DI: M9431002230000
·
Model: 10-0223-000
·
Spinal Simplicity, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Minuteman
- Primary DI
- M9431002230000
- Version / Model
- 10-0223-000
- Company Name
- Spinal Simplicity, LLC
- Labeler DUNS
- 963359513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-23
- Public Version
- 1
- Public Version Date
- 2026-03-03
- Public Version Status
- New
- Public Device Record Key
- 778b48f9-1b6c-45c7-9c28-62b7728d074c
Device Description
Minuteman G6, 14mm
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
- MR Conditional
- Direct Marking Exempt
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PEK | Spinous Process Plate | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65133 | Instrument tray corner protector, single-use | A device designed to cover the sharp corners of an instrument tray before the tray is wrapped with sterilization packaging (wrap), to protect the wrap from tearing and the tray corners from damage. It is typically made of synthetic polymer materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M9431002230000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253250 | 000 |