FDA UDI
In Commercial Distribution
🇺🇸 United States
Leipzig-style cone ø30-45 mm, with holder and guide
DI: 00810563022780
·
Model: GM11010170
·
VARIAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Leipzig-style cone ø30-45 mm, with holder and guide
- Primary DI
- 00810563022780
- Version / Model
- GM11010170
- Catalog Number
- GM11010170
- Company Name
- VARIAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 009120817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-06
- Public Version
- 1
- Public Version Date
- 2025-10-14
- Public Version Status
- New
- Public Device Record Key
- 3f4bec0d-0940-4dda-a169-fdd3ebef29f1
Device Characteristics
- Single Use
- No
- 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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38436 | General-purpose brachytherapy system applicator, remote-afterloading | A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810563022780 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123815 | 000 |