FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable steel needle, 17G, L=200mm
DI: 04065983002850
·
Model: 05
·
BEBIG Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Disposable steel needle, 17G, L=200mm
- Primary DI
- 04065983002850
- Version / Model
- 05
- Catalog Number
- LLA210-S
- Company Name
- BEBIG Medical GmbH
- Labeler DUNS
- 343363100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-09-18
- Public Version
- 1
- Public Version Date
- 2024-09-26
- Public Version Status
- New
- Public Device Record Key
- 08455a2d-254d-4523-b8f8-74eb5b3e570e
Device Description
The Disposable Steel Needles are intended for interstitial brachytherapy applications.
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 38300 | Remote-afterloading brachytherapy system | An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04065983002850 | GS1 | ||||
| Unit of Use | 04065983000962 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142986 | 000 |