FDA UDI
In Commercial Distribution
🇺🇸 United States
Genesys HTA ProCerva
DI: 00850033976038
·
Model: M006580210
·
Minerva Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Genesys HTA ProCerva
- Primary DI
- 00850033976038
- Version / Model
- M006580210
- Catalog Number
- M006580210
- Company Name
- Minerva Surgical, Inc.
- Labeler DUNS
- 829616478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-08
- Public Version
- 1
- Public Version Date
- 2022-06-16
- Public Version Status
- New
- Public Device Record Key
- a289ace3-e8e8-4813-87c2-d92737c9ef52
Device Description
Procedure Set including Procedure Sheath, Cassette, Drainage Bag
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58864 | Circulating-fluid endometrial-ablation catheter | A device in the form of a thin tube with an inflatable balloon at its distal tip intended to be used to provide heat ablation (typically at a temperature of approximately 150°C) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is designed to be attached to a hand-held control unit in which a fluid medium (e.g., glycerin) is heated before being forced into the catheter balloon under pressure to compress against the uterine wall and circulate within for homogenous heat distribution. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033976038 | GS1 | ||||
| Previous | 08714729809456 | GS1 | ||||
| Package | 00850033976045 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 855-646-7874
- [email protected]