FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpha VI 30mm Transfer Device
DI: M097TDA20300
·
Model: TDA-2030
·
BEST VASCULAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alpha VI 30mm Transfer Device
- Primary DI
- M097TDA20300
- Version / Model
- TDA-2030
- Catalog Number
- TDA-2030
- Company Name
- BEST VASCULAR, INC.
- Labeler DUNS
- 789032039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 53d0cac0-f3e6-44b8-a545-498ed08c474b
Device Description
Alpha VI 30mm Transfer Device for the Beta-Cath System
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MOU | Intravascular Radiation Delivery System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61706 | Manual-afterloading brachytherapy system source transfer device | A portable, battery-powered, hydraulically-operated, hand-held device intended to store and deliver/remove a therapeutic or palliative radiation dose to/from an anatomical region. It is designed to temporarily or permanently place a radioactive source on/in the treatment site through a connected applicator (e.g., coronary artery catheter) that has been previously introduced in the patient, and typically includes a sensor to monitor the position of the radioactive source. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M097TDA20300 | HIBCC |
Customer Contacts
- Phone
- 770-717-0904
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000018 | 000 |
| P000018 | 015 |
| P000018 | 035 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius