FDA UDI
In Commercial Distribution
🇺🇸 United States
Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin
DI: 00810563021981
·
Model: GM11014730
·
Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin
- Primary DI
- 00810563021981
- Version / Model
- GM11014730
- Catalog Number
- GM11014730
- Company Name
- Varian Medical Systems Deutschland GmbH
- Labeler DUNS
- 332474605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-16
- Public Version
- 3
- Public Version Date
- 2026-01-14
- Public Version Status
- Update
- Public Device Record Key
- 3d8ab4ef-bb63-4cfa-8d38-1d486a8010c7
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10810563021988 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00810563021981 | GS1 | ||||
| Package | 20810563021985 | GS1 | 20 | In Commercial Distribution |