FDA UDI
In Commercial Distribution
🇺🇸 United States
Best Medical International
DI: 00841365113192
·
Model: 1921-26
·
BEST MEDICAL INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Best Medical International
- Primary DI
- 00841365113192
- Version / Model
- 1921-26
- Company Name
- BEST MEDICAL INTERNATIONAL, INC.
- Labeler DUNS
- 086352655
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- aee6776e-cf88-4e0a-8c51-63e66d457b7d
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 59686 | Intraoperative/postoperative therapeutic x-ray system balloon applicator kit | A sterile collection of devices that is a component of an intraoperative/postoperative therapeutic x-ray system designed for the administration of radiation in certain clinical applications, typically intraoperatively within a resected breast tumour bed. It typically consists of a set of cavity ball gauges used for measurement of the cavity, and a set of graduated size balloon applicators. The required size of applicator is intended to be placed in the tumour cavity after lumpectomy and inflated, and the inner catheter is designed to hold the tube of the x-ray source, stabilized by a probe guard, during radiotherapy treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841365113192 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132097 | 000 |