FDA UDI
In Commercial Distribution
🇺🇸 United States
16 Ch AI BREAST COIL 1.5T
DI: 04260487680034
·
Model: 10185781 02
·
RAPID Biomedical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 16 Ch AI BREAST COIL 1.5T
- Primary DI
- 04260487680034
- Version / Model
- 10185781 02
- Company Name
- RAPID Biomedical GmbH
- Labeler DUNS
- 316037741
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-29
- Public Version
- 2
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 813c1f03-bb08-4b7b-8b3a-5cfed72c0cf6
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
- 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 |
|---|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40749 | MRI system coil, radio-frequency | A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260487680034 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083255 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 40 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 24 Degrees Celsius