FDA UDI
In Commercial Distribution
🇺🇸 United States
Small component box to store small componenets during reprocessing
DI: 00816389020139
·
Model: GM11012300
·
Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Small component box to store small componenets during reprocessing
- Primary DI
- 00816389020139
- Version / Model
- GM11012300
- Catalog Number
- GM11012300
- 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
- 2017-11-23
- Public Version
- 4
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 9499a14f-7bbc-41ad-8262-1e4aff1c9988
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
- 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 |
|---|---|---|---|---|
| 38407 | Vaginal brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816389020139 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160021 | 000 |