FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilization Box for Fletcher-style applicators, defined geometry,
DI: 00816389028364
·
Model: GM11010320
·
Varian Medical Systems Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sterilization Box for Fletcher-style applicators, defined geometry,
- Primary DI
- 00816389028364
- Version / Model
- GM11010320
- Catalog Number
- GM11010320
- 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
- 2020-09-27
- Public Version
- 5
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 8a2fbceb-faba-46cb-93e5-8282cf0437bd
Device Description
(GM11000810 & GM11006200)
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
- 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
- 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 |
|---|---|---|---|---|
| 13730 | Device sterilization/disinfection container, reusable | A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816389028364 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160021 | 000 |