FDA UDI
In Commercial Distribution
🇺🇸 United States
R-300
DI: 04540217062461
·
Model: 566-17970-90
·
SHIMADZU CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- R-300
- Primary DI
- 04540217062461
- Version / Model
- 566-17970-90
- Company Name
- SHIMADZU CORPORATION
- Labeler DUNS
- 690558747
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 1
- Public Version Date
- 2020-04-13
- Public Version Status
- New
- Public Device Record Key
- 41adfe7e-fe46-486e-92fa-8293f3d673a7
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
- 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 |
|---|---|---|---|---|
| IZX | Collimator, Manual, Radiographic | Radiology | 892.1610 | 2 |
| IZW | Collimator, Automatic, Radiographic | Radiology | 892.1610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33136 | Automatic-aperture-control diagnostic x-ray system collimator | A standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It typically includes a light-centring device that is used to project a light field onto the patient that is coincident with the x-ray beam in order to centre the tube over the film cassette. It is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04540217062461 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101039 | 000 |