FDA UDI
In Commercial Distribution
🇺🇸 United States
Beam Block Set, High Energy
DI: B365534260
·
Model: 53-426
·
Aktina Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Beam Block Set, High Energy
- Primary DI
- B365534260
- Version / Model
- 53-426
- Company Name
- Aktina Corp.
- Labeler DUNS
- 787178920
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 53c5aa42-2a73-4b7a-9a06-0aa8cb7344dd
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
- 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 |
|---|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | Radiology | 892.5710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42262 | Manual-aperture-control therapeutic x-ray system collimator, non-motorized | A non-motorized, x-ray beam-limiting and shaping device that is a component of a therapeutic x-ray system and that is adjusted manually. It is attached to the x-ray tube housing assembly and adjusts the size and shape of the x-ray beam to match the size and shape of a predefined target area or the shape of a x-ray cassette used for quality assurance purposes. It is used in radiation therapy applications to limit the effects of scattered radiation and to provide patient protection by limiting or eliminating exposure to non-target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B365534260 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974239 | 000 |