FDA UDI
In Commercial Distribution
🇺🇸 United States
Faxitron
DI: 00857069006197
·
Model: VersaVision 12x15
·
FAXITRON BIOPTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Faxitron
- Primary DI
- 00857069006197
- Version / Model
- VersaVision 12x15
- Company Name
- FAXITRON BIOPTICS, LLC
- Labeler DUNS
- 968877360
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-04
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 200a85dd-3091-4a2f-9f20-ff3baba6674d
Device Description
Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MWP | Cabinet,X-Ray System | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42282 | Stationary specimen x-ray system, digital | A stationary specimen x-ray system designed for permanent fixture in one location to generate and control x-ray beams and to record the absorption patterns of x-rays passing through tissue samples (e.g., stereotactic biopsy cores taken during mammographic procedures) or amputated body parts. The data is either from analogue imaging and digitized afterwards or by digital imaging. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857069006197 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170786 | 000 |