FDA UDI
In Commercial Distribution
🇺🇸 United States
Support cushion Breast BI 7
DI: 04251269202667
·
Model: 01
·
Noras MRI products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Support cushion Breast BI 7
- Primary DI
- 04251269202667
- Version / Model
- 01
- Catalog Number
- 118770
- Company Name
- Noras MRI products GmbH
- Labeler DUNS
- 312844095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-28
- Public Version
- 5
- Public Version Date
- 2021-04-08
- Public Version Status
- Update
- Public Device Record Key
- 70f14058-f1f1-49bf-a767-ed7ef1542a4f
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
- 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 |
|---|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40740 | Medical-imaging cine projector | A device through which the developed film from cinematic (cine) cameras used in various medical imaging applications is intended to be retrospectively reviewed as motion pictures. Depending on the system design it will typically accommodate either 16 or 35-mm film formats and is typically used in conjunction with diagnostic x-ray systems, endoscopic systems, or diagnostic ultrasound systems. The basic components of a cine projector (also known as a movie or film projector) include a film transport mechanism, a light source with condenser optics, and imaging optics. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251269202667 | GS1 |
Customer Contacts
- Phone
- +490931299270
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162651 | 000 |