FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Intrauterine Tube, bent; IUL=35mm, 40°
DI: 04049223108359
·
Model: LAR05-01
·
Eckert & Ziegler BEBIG GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Intrauterine Tube, bent; IUL=35mm, 40°
- Primary DI
- 04049223108359
- Version / Model
- LAR05-01
- Catalog Number
- LAR05-01
- Company Name
- Eckert & Ziegler BEBIG GmbH
- Labeler DUNS
- 331080432
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-06
- Public Version
- 4
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- ebb32332-f6d2-4ee4-b9a9-bfc3bcc13fea
- Distribution End Date
- 2024-02-28
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 38409 | Cervical/intrauterine brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049223108359 | GS1 |
Customer Contacts
- Phone
- +4930941084130
- [email protected]