FDA UDI
In Commercial Distribution
🇺🇸 United States
Esophagus bougie diameter 10 mm, with bite protector and fixation
DI: 00816389024151
·
Model: GM11007420
·
Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Esophagus bougie diameter 10 mm, with bite protector and fixation
- Primary DI
- 00816389024151
- Version / Model
- GM11007420
- Catalog Number
- GM11007420
- 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
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f62c722c-f1d1-4572-81df-4477c6ca30d0
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 | 00816389024151 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130251 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 10 | Millimeter |