FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10886982362193
·
Model: SD03.233.017
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 10886982362193
- Version / Model
- SD03.233.017
- Catalog Number
- SD03233017
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-10
- Public Version
- 1
- Public Version Date
- 2026-01-19
- Public Version Status
- New
- Public Device Record Key
- 351f19a0-212c-424b-b3cb-36083f29811d
Device Description
CALIBRATION UNIT RFNA PROXIMAL AIMING 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
- 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 |
|---|---|---|---|---|
| FZX | Guide, surgical, instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47786 | Orthopaedic implant aiming arm | A surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886982362193 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]