FDA UDI
In Commercial Distribution
🇺🇸 United States
Alatus
DI: H787VBP400
·
Model: VBP-40
·
ANGIODYNAMICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Alatus
- Primary DI
- H787VBP400
- Version / Model
- VBP-40
- Company Name
- ANGIODYNAMICS, INC.
- Labeler DUNS
- 079105071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-02
- Public Version
- 1
- Public Version Date
- 2024-01-10
- Public Version Status
- New
- Public Device Record Key
- 9f337522-a769-481e-b5a9-fea3db11a0f0
Device Description
Alatus Vaginal Balloon Packing System
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
- MR Conditional
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| JAQ | System, applicator, radionuclide, remote-controlled | Radiology | 892.5700 | 2 |
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65704 | Radiation therapy lesion localization urethral catheter, planning | A flexible tube with a non-powered radiopaque marker (e.g., barium) at its distal end intended to be introduced into the prostatic urethra, to create an identifying mark, for the alignment and monitoring of a patient's tumour/lesion position relative to the isocentre of a radiation therapy system during treatment planning. It may allow urinary drainage or incorporate a balloon for stabilization. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | 15051684018913 | GS1 | ||||
| Primary | H787VBP400 | HIBCC |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092534 | 000 |