FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bougie for Oesophagus, single-use, D=10mm (30Fr)
DI: 04049223116507
·
Model: LAZ24-10
·
Eckert & Ziegler BEBIG GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bougie for Oesophagus, single-use, D=10mm (30Fr)
- Primary DI
- 04049223116507
- Version / Model
- LAZ24-10
- Catalog Number
- LAZ24-10
- 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
- 2016-10-05
- Public Version
- 4
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 413aa65e-177d-4a70-bd78-23dbd089425e
- Distribution End Date
- 2024-02-28
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38421 | Oesophagus brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the oesophagus. It is designed for temporary implantation within the oesophageal region and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of oesophageal 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 | 04049223116507 | GS1 |
Customer Contacts
- Phone
- +4930941084130
- [email protected]