FDA UDI
In Commercial Distribution
🇺🇸 United States
Milling Drum Extra Extra Extra Fine
DI: 08720254007861
·
Model: SMT-SBM-1207-59
·
Spierings Orthopaedics B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Milling Drum Extra Extra Extra Fine
- Primary DI
- 08720254007861
- Version / Model
- SMT-SBM-1207-59
- Company Name
- Spierings Orthopaedics B.V.
- Labeler DUNS
- 407288690
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- c170ce2e-2f7e-4c0a-9052-10d61d3a8e6c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LYS | Bone Mill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18129 | Manual bone mill | A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720254007861 | GS1 |