FDA UDI
In Commercial Distribution
🇺🇸 United States
Advantage-Strand® with Advantage Pd-103®
DI: M936PBKAS9
·
Model: PBKA
·
ISOAID, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
9
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Basic Information
- Brand Name
- Advantage-Strand® with Advantage Pd-103®
- Primary DI
- M936PBKAS9
- Version / Model
- PBKA
- Company Name
- ISOAID, L.L.C.
- Labeler DUNS
- 002751241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9
- Record Status
- Published
- Publish Date
- 2016-02-04
- Public Version
- 4
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- 669ed8a1-f43f-4894-b2a6-8996af864488
Device Description
Advantage-Strand® with Advantage Pd-103® radioactive seeds.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | Radiology | 892.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33069 | Brachytherapy injection needle | A 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 | M936PBKAS9 | HIBCC | ||||
| Unit of Use | M936PBKAS | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091117 | 000 |