FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIONIX RADIATION THERAPY
DI: 00817740021017
·
Model: ERB-90-FS
·
Bionix Radiation Therapy, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIONIX RADIATION THERAPY
- Primary DI
- 00817740021017
- Version / Model
- ERB-90-FS
- Catalog Number
- ERB-90-FS
- 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
- 876fd4b0-f8ff-44dd-bc03-3effa2ac6488
- Distribution End Date
- 2019-08-30
Device Description
ENDORECTAL BALLOON
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PCT | Prostate immobilizer rectal balloon | Radiology | 892.5720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62434 | Prostate immobilization balloon catheter | A non-sterile flexible tube with an inflatable balloon at its distal end intended to be inserted into the rectum to facilitate adequate positioning and immobilization of the prostate during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817740021014 | GS1 | box | 12 | Not in Commercial Distribution | 2019-08-30 |
| Primary | 00817740021017 | GS1 |
Customer Contacts
- Phone
- +1(800)624-6649
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | OUTER DIAMETER | ||
| Device Size Text, specify | LENGTH | ||
| Outer Diameter | 41.5 | Millimeter | |
| Length | 90 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY ENVIRONMENT