FDA.reportPublic FDA data

Genesys HTA ProCerva

Primary DI
00850033976038
Brand
Genesys HTA ProCerva
Company
Minerva Surgical, Inc.
Model
M006580210
Catalog number
M006580210
Device description
Procedure Set including Procedure Sheath, Cassette, Drainage Bag
Published
2022-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNBDevice, Thermal Ablation, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNBDevice, Thermal Ablation, EndometrialUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033976045PackageGS15In Commercial Distribution
08714729809456PreviousGS10
00850033976038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033976045008500339760458500339760450850033976045
08714729809456087147298094568714729809456
00850033976038008500339760388500339760380850033976038

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid endometrial-ablation catheterA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-646-7874customerservice@minervasurgical.com

Regulatory Flags#

DUNS number
829616478
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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00850033976380HERizon Vista Single Use Hysteroscope, DiagnosticSH-02ASH-02A2026-04-01
00850033976397HERizon Vista Single Use Hysteroscope, Model 2SH-02BSH-02B2026-04-01
00850033976403HERizon Vista Single Use Hysteroscope, PlusSH-04BSH-04B2026-04-01
00850033976410HERizon Vista Single Use Hysteroscope, ProSH-03C2026-04-01
00850033976359HERizon Disposable Endoscopic Scissors XLJY-JD-17-450-BJY-JD-17-450-B2026-02-13
00850033976342Symphion Operative Hysteroscopy System Prime Controller- RefurbishedFG-PRIME25-RFG-PRIME25-R2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLJY-JD-17-450-BJY-JD-17-450-B2026-02-13
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLJY-CC-450-18-SJY-CC-450-18-S2026-02-12
00850033976335Symphion Operative Hysteroscopy System Prime ControllerFG-PRIME25FG-PRIME252025-10-31
00850033976298HERizon Disposable Endoscopic Forceps – Alligator JY-CC-350-18-SJY-CC-350-18-S2024-10-07
00850033976311HERizon Disposable Endoscopic ScissorsJY-JD-17-350-BJY-JD-17-350-B2024-10-07
00850033976267HERizon Disposable Electronic HysteroscopeJY-DEH-001JY-DEH-0012024-10-07
00850033976274HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
00850033976281HERizon Disposable Endoscopic Forceps - Foreign Body GrasperJY-C-350-18-SJY-C-350-18-S2024-10-07
00850033976304HERizon Disposable Endoscopic Forceps - Inverted ToothJY-DC-350-18-SJY-DC-350-18-S2024-10-07
00850033976250HERizon Medical Endoscope Image Processor JY-MIP-1000JY-MIP-10002024-10-07
10850033976264HERizon Disposable Electronic HysteroscopeJY-DEH-001JY-DEH-0012024-10-07
10850033976271HERizon Disposable Endoscopic Forceps - BiopsyJY-PK-350-18-SJY-PK-350-18-S2024-10-07
10850033976288HERizon Disposable Endoscopic Forceps - Foreign Body GrasperJY-C-350-18-SJY-C-350-18-S2024-10-07

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00850044503162MinitouchMicrocube, LLCMNB2023-10-18
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