FDA UDI
In Commercial Distribution
🇺🇸 United States
Symphion Controller
DI: 00850033976090
·
Model: FG-0612
·
Minerva Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Symphion Controller
- Primary DI
- 00850033976090
- Version / Model
- FG-0612
- Catalog Number
- FG-0612
- Company Name
- Minerva Surgical, Inc.
- Labeler DUNS
- 829616478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-03
- Public Version
- 1
- Public Version Date
- 2022-05-11
- Public Version Status
- New
- Public Device Record Key
- fd584ad3-8849-4f92-965a-700fa0b7674b
Device Description
Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Contents: (1) Symphion Controller (1) Power Cord (1) Footswitch (1) Saline Pole
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | Obstetrics/Gynecology | 884.1710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63308 | Electrolytic-plasma electrosurgical system | An assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033976090 | GS1 | ||||
| Previous | 08714729863687 | GS1 |
Customer Contacts
- Phone
- 855-646-7874
- [email protected]