FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIONIX RADIATION THERAPY
DI: 00817740020980
·
Model: E-APP-1
·
Bionix Radiation Therapy, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIONIX RADIATION THERAPY
- Primary DI
- 00817740020980
- Version / Model
- E-APP-1
- Catalog Number
- E-APP-1
- Company Name
- Bionix Radiation Therapy, LLC
- Labeler DUNS
- 080397923
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-25
- Public Version
- 4
- Public Version Date
- 2023-07-10
- Public Version Status
- Update
- Public Device Record Key
- 4510459c-cdb1-4489-a17c-b6ca4ee5e0fb
- Distribution End Date
- 2019-08-30
Device Description
ESOPHAGEAL APPLICATOR
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAQ | System, applicator, radionuclide, remote-controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38421 | Oesophagus brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the oesophagus. It is designed for temporary implantation within the oesophageal region and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of oesophageal applicators, e.g., hollow needles, tubes, or catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817740020980 | GS1 |
Customer Contacts
- Phone
- +1(800)624-6649
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 11 | Centimeter | |
| Outer Diameter | 20 | Millimeter | |
| Device Size Text, specify | BALLOON OUTER DIAMETER | ||
| Device Size Text, specify | TREATMENT LENGTH OF BALLOONS |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY ENVIRONMENT