FDA UDI
In Commercial Distribution
🇺🇸 United States
RESTORIS, RIO
DI: 00848486022204
·
Model: 207084
·
MAKO SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RESTORIS, RIO
- Primary DI
- 00848486022204
- Version / Model
- 207084
- Catalog Number
- 207084
- Company Name
- MAKO SURGICAL CORP.
- Labeler DUNS
- 175239677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-06-08
- Public Version Status
- Update
- Public Device Record Key
- ea3a1697-60f4-47c3-b0af-8369492fb1e8
Device Description
REAMER HANDLE, STRAIGHT
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 |
|---|---|---|---|---|
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37868 | Surgical power tool system handpiece, reaming, pneumatic | A hand-held, pneumatically-powered device intended to provide torque specifically for reaming during surgical procedures. The device typically includes a chuck or collet to grip a reamer (e.g., an orthopaedic intramedullary canal reamer), and it usually provides a high torque for heavy reaming; the reaming endpiece is not included. The device is usually cannulated to allow for use of a guidewire. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848486022204 | GS1 |