FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System
DI: 00801741078514
·
Model: IS200
·
Bard Brachytherapy, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System
- Primary DI
- 00801741078514
- Version / Model
- IS200
- Catalog Number
- IS200
- Company Name
- Bard Brachytherapy, Inc.
- Labeler DUNS
- 185524860
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-05
- Public Version
- 5
- Public Version Date
- 2023-10-09
- Public Version Status
- Update
- Public Device Record Key
- 2976e508-c14b-470c-a1b8-134899913913
- Distribution End Date
- 2021-06-15
Device Description
Model 200 TheraSeed® Palladium-103 Seeds IN ISOSLEEVE, STRL
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
| 33069 | Brachytherapy needle | A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741078514 | GS1 | ||||
| Package | 10801741078511 | GS1 | Other | 1 | Not in Commercial Distribution | 2021-06-15 |
Customer Contacts
- Phone
- +1(800)977-6733
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060636 | 000 |