FDA UDI
In Commercial Distribution
🇺🇸 United States
Seed Implant Needle
DI: 10801741075923
·
Model: 718205
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Seed Implant Needle
- Primary DI
- 10801741075923
- Version / Model
- 718205
- Catalog Number
- 718205
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- 42cc12b6-f4d2-4fc7-bed4-cf5d11b594e6
Device Description
BrachyStar Seed Implant Needle, With Antistatic Plastic Hub and Lubricious Coating, 18g x 20cm Length
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20801741075920 | GS1 | CA | 10 | In Commercial Distribution | |
| Primary | 10801741075923 | GS1 | ||||
| Unit of Use | 00801741075926 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 18 | Gauge |