FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MRI Antenna Coil Cover
DI: 07630016857751
·
Model: CI-7521
·
Advanced Bionics AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MRI Antenna Coil Cover
- Primary DI
- 07630016857751
- Version / Model
- CI-7521
- Company Name
- Advanced Bionics AG
- Labeler DUNS
- 485262658
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-22
- Public Version
- 5
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- db6ab70c-1f65-4faa-9944-1987d45adf07
- Distribution End Date
- 2024-03-19
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCM | Implant, Cochlear | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63638 | Cochlear implant implantable magnet MRI shield | A non-sterile device intended to secure the implantable magnet in the cochlear implant system in the presence of the magnetic field produced by a magnetic resonance imaging (MRI) system, to prevent displacement of the magnet during an MRI procedure. It is intended to be placed externally on the head of the patient directly over the implant, typically using a bandage(s) and/or tape(s); it is made of synthetic polymer materials (e.g., polycarbonate, polyester). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630016857751 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 121 |