FDA UDI
In Commercial Distribution
🇺🇸 United States
Hot Wire Cutter
DI: B365530460
·
Model: 53-046
·
Aktina Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hot Wire Cutter
- Primary DI
- B365530460
- Version / Model
- 53-046
- 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
- 461608bf-7516-4330-a6d2-223858e1a931
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 |
|---|---|---|---|---|
| 37079 | Radiation therapy beam block production hot-wire | A mains electricity (AC-powered) device designed with a thin electrically-heated wire (hot-wire) that is used in the manual production of radiation therapy beam blocks (custom-made radiation collimators) which are used to configure a patient specific radiation field. The hot-wire is used to cut out the required patterns (the moulds) in a special Styrofoam material, e.g., Styrodur that will become templates used in the casting of a beam block(s). These moulds are configured from precise modelling data of the area to be treated for each individual patient thereby enabling production of exact beam blocks that control the treatment area during the radiotherapy treatment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B365530460 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973953 | 000 |