FDA UDI
In Commercial Distribution
🇺🇸 United States
Brachytherapy Kit
DI: B16556550323093024039
·
Model: 5655
·
Liberty Medical , Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Brachytherapy Kit
- Primary DI
- B16556550323093024039
- Version / Model
- 5655
- Company Name
- Liberty Medical , Inc.
- Labeler DUNS
- 967592978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-15
- Public Version
- 1
- Public Version Date
- 2024-04-23
- Public Version Status
- New
- Public Device Record Key
- 81384f34-2655-4070-91b8-4d3f2c814109
Device Description
(1) 5653- 15ga, 30cm catheter w/button. 5/pk (1) 5654- 17ga, 20cm implant needles w/stylet, 5/pk (1) 5910- buttons, 5/pk, assorted colors (1) 5647- catheter caps 15ga 10/pk
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | Radiology | 892.5650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38426 | Prostate brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B16556550323093024039 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 15 | Gauge |