FDA UDI
In Commercial Distribution
🇺🇸 United States
BrachySource™
DI: 00801741078217
·
Model: PS1251C
·
Bard Brachytherapy, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BrachySource™
- Primary DI
- 00801741078217
- Version / Model
- PS1251C
- Catalog Number
- PS1251C
- Company Name
- Bard Brachytherapy, Inc.
- Labeler DUNS
- 185524860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-05
- Public Version
- 4
- Public Version Date
- 2024-08-28
- Public Version Status
- Update
- Public Device Record Key
- 0b7ab698-dba8-44bf-a42e-ed303af86759
Device Description
BrachySource™ I-125 Implant Seed in Cartridges, Non-Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXK | Source, brachytherapy, radionuclide | Radiology | 892.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38303 | Manual brachytherapy source, permanent implant | A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles. | Yes | Active |
| 38435 | General-purpose brachytherapy system applicator, manual | A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741078217 | GS1 |
Customer Contacts
- Phone
- +1(800)977-6733
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093663 | 000 |