FDA UDI
In Commercial Distribution
🇺🇸 United States
3D Imaging C-Arm Table, 115V
DI: 00879942070514
·
Model: 058-820
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3D Imaging C-Arm Table, 115V
- Primary DI
- 00879942070514
- Version / Model
- 058-820
- Catalog Number
- 058-820
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-26
- Public Version
- 1
- Public Version Date
- 2023-07-04
- Public Version Status
- New
- Public Device Record Key
- adbc4ec2-9693-42ec-8995-93a41be55fc4
Device Description
The 3D Imaging C-Arm Table 820 is designed and equipped for use with 3D imaging rings and 3D C-Arms for general C-Arm and O-Arm applications. The table features motorized actuation of height, X-Y, lateral roll and Trendelenburg motions of the tabletop.
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
- Yes
- 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 |
|---|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40658 | Fluoroscopy/angiography table, powered | A powered table designed to support and position a patient during fluoroscopy/angiography typically in conjunction with a cardiovascular intervention or other minimally-invasive surgical intervention (e.g., biopsy). It has a flat table top with electronic controls for table top positioning and/or motion relative to the x-ray beam. It is not dedicated to breast biopsy, and is not intended for other specialized surgeries (i.e., it is not a specialized operating table with x-ray transparent features). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00879942070514 | GS1 |
Customer Contacts
- Phone
- 201-825-9500
- [email protected]