FDA UDI
In Commercial Distribution
🇺🇸 United States
ANKE
DI: 06950743801058
·
Model: ASM-050P (OPENMARK 5000)
·
Shenzhen Anke High-Tech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANKE
- Primary DI
- 06950743801058
- Version / Model
- ASM-050P (OPENMARK 5000)
- Company Name
- Shenzhen Anke High-Tech Co., Ltd.
- Labeler DUNS
- 653717256
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c16c35ae-61de-42f1-8e96-a9abcdceb4e9
Device Description
Magnetic Resonance Imaging System, Model: ASM-050P or OPENMARK 5000
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37652 | Full-body MRI system, permanent magnet | A general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06950743801058 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113281 | 000 |