FDA UDI
In Commercial Distribution
🇺🇸 United States
Tx/Rx Knee 18 Coil Kit 3T
DI: 04056869022970
·
Model: 10840788
·
Siemens Shenzhen Magnetic Resonance Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tx/Rx Knee 18 Coil Kit 3T
- Primary DI
- 04056869022970
- Version / Model
- 10840788
- Company Name
- Siemens Shenzhen Magnetic Resonance Ltd.
- Labeler DUNS
- 544891302
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-26
- Public Version
- 4
- Public Version Date
- 2021-11-17
- Public Version Status
- Update
- Public Device Record Key
- 9663363b-bd1e-4b86-a5f4-443976c9d611
Device Description
contains Medical Device Mat.: 10840787 (GTIN: 04056869053431)
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
| MOS | Coil, magnetic resonance, specialty | Radiology | 892.1000 | 2 |
| LNI | System, nuclear magnetic resonance spectroscopic | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37654 | Full-body MRI system, superconducting magnet | A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056869022970 | GS1 |
Customer Contacts
- Phone
- +1(800)888-7436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170396 | 000 |