FDA UDI
In Commercial Distribution
🇺🇸 United States
Sound Pro Combination Ultrasound Table, 115V
DI: 00879942070613
·
Model: 058-710
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sound Pro Combination Ultrasound Table, 115V
- Primary DI
- 00879942070613
- Version / Model
- 058-710
- Catalog Number
- 058-710
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-14
- Public Version
- 1
- Public Version Date
- 2023-07-24
- Public Version Status
- New
- Public Device Record Key
- 6474f49b-6e49-4f3b-b08e-faa6722ef937
Device Description
Fully equipped for OB/GYN, general ultrasound and echocardiography procedures with extra-wide tabletop and cardiac cut outs. Includes hand and foot controllers to activate height, Trendelenburg motions and Fowler positioning.
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
- 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 |
|---|---|---|---|---|
| 62694 | Ultrasound imaging system table, powered | An electrically-powered flat or curved-top table specifically designed to position and support a patient during diagnostic procedures involving the use of an ultrasound imaging system; it is not primarily intended for interventional procedures/surgery or x-ray imaging. It has electronic and/or software controls for tabletop height and positioning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00879942070613 | GS1 |
Customer Contacts
- Phone
- 201-825-9500
- [email protected]