FDA UDI
In Commercial Distribution
🇺🇸 United States
Summit
DI: B307S1050
·
Model: S105
·
SUMMIT INDUSTRIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Summit
- Primary DI
- B307S1050
- Version / Model
- S105
- Catalog Number
- S105
- Company Name
- SUMMIT INDUSTRIES, LLC
- Labeler DUNS
- 130235187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-07
- Public Version
- 5
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- 4f330f56-51b5-4304-9aac-ab525d76612b
Device Description
RADIOGRAPHIC TUBESTAND
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
- 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 |
|---|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | Radiology | 892.1770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37076 | X-ray system tube support, floor standing | A component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be placed on the floor to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls mounted on a base plate. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B307S1050 | HIBCC |
Customer Contacts
- Phone
- +17733534000
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry