FDA UDI
In Commercial Distribution
🇺🇸 United States
Lateral Cassette Holder, Siemens Compatible
DI: B365529560
·
Model: 52-956
·
Aktina Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lateral Cassette Holder, Siemens Compatible
- Primary DI
- B365529560
- Version / Model
- 52-956
- Company Name
- Aktina Corp.
- Labeler DUNS
- 787178920
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-21
- Public Version
- 1
- Public Version Date
- 2021-05-31
- Public Version Status
- New
- Public Device Record Key
- c7289310-4c32-4112-ba92-6b957257ebc6
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
- Yes
- 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 |
|---|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | Radiology | 892.1880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36914 | Radiation therapy port film device | A motorized cassette holder that is either mounted on the gantry of, e.g., a linear accelerator system or other radiation therapy system, or is designed as an independent mobile stand, and is used to position and support a film cassette. The x-ray or radiographic film in the cassette is exposed in order to allow the operators to monitor and adjust the conformity between the planned radiation treatment and the treatment delivered to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B365529560 | HIBCC |