FDA UDI
In Commercial Distribution
🇺🇸 United States
Carbon offset reamer handle Stryker / Zimmer-Hall dual coupling
DI: 07640187914009
·
Model: T17874
·
MPS Micro Precision Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carbon offset reamer handle Stryker / Zimmer-Hall dual coupling
- Primary DI
- 07640187914009
- Version / Model
- T17874
- Catalog Number
- T17874
- Company Name
- MPS Micro Precision Systems AG
- Labeler DUNS
- 482204059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 2
- Public Version Date
- 2022-11-18
- Public Version Status
- Update
- Public Device Record Key
- 7700afa0-8e71-4263-88d3-5c08e1987687
Device Description
Offset Reamer handles designed for required minimally invasive surgical approach of the hip joint. A non clipped and dual connection with reamer cutting tool and 3 couplings with power tool (Big AO, Stryker-Zimmer/Hall and Hudson) are available. It could be disassembled in 5 parts allowing the cleaning of the instrument. This is a reusable device.
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
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47845 | Surgical power tool adaptor | A connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640187914009 | GS1 |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]