FDA.reportPublic FDA data

Her Option

Primary DI
00888937000016
Brand
Her Option
Company
Coopersurgical, Inc.
Model
CG-1
Device description
Her Option Console
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNBDevice, Thermal Ablation, Endometrial

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000032000HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEMCooperSurgical, Inc.2001-04-20MNB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937000016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937000016008889370000168889370000160888937000016

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, electronicAn assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060488046858EZ-Strip131µm7-72-1131/202025-04-11
05060488046865EZ-Strip135µm7-72-1135/202025-04-11
05060488046872EZ-Strip145µm7-72-1145/202025-04-11
05060488046889EZ-Strip145µm Long7-72-1145L/202025-04-11
05060488046896EZ-Strip155µm7-72-1170/202025-04-11
05060488046902EZ-Strip170µm7-72-1170/202025-04-11
05060488046919EZ-Strip200µm7-72-1290/202025-04-11
05060488046926EZ-Strip290µm7-72-1290/202025-04-11
05060488046933EZ-Strip290µm7-72-1600/202025-04-11
05060488046940EZ-Tip75µm7-72-2075/12025-04-11
05060488046957EZ-Tip125µm7-72-2125/12025-04-11
05060488046964EZ-Tip135µm7-72-2135/12025-04-11
05060488046971EZ-Tip145µm7-72-2145/12025-04-11
05060488046988EZ-Tip155µm7-72-2155/12025-04-11
05060488046995EZ-Tip170µm7-72-2170/12025-04-11
05060488047008EZ-Tip200µm7-72-2200/12025-04-11
05060488047015EZ-Tip250µm7-72-2250/12025-04-11
05060488047022EZ-Tip290µm7-72/2290/12025-04-11
05060488047039EZ-Tip600µm7-72-2600/12025-04-11
05060488047046EZ-Tip75µm7-72-2075/52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937026870Mara ConsoleCoopersurgical, Inc.MNB2024-03-13
00888937026887Mara Coopersurgical, Inc.MNB2023-12-01
00850044503018MinitouchMicrocube, LLCMNB2023-10-18
00850044503117MinitouchMicrocube, LLCMNB2023-10-18
00850044503124MinitouchMicrocube, LLCMNB2023-10-18
00850044503131MinitouchMicrocube, LLCMNB2023-10-18
00850044503148MinitouchMicrocube, LLCMNB2023-10-18
00850044503155MinitouchMicrocube, LLCMNB2023-10-18
00850044503162MinitouchMicrocube, LLCMNB2023-10-18
00850044503209MinitouchMicrocube, LLCMNB2023-10-18
10850044503015MinitouchMicrocube, LLCMNB2023-10-18
15420045515154NovaSureHologic, Inc.MNB2023-04-22
00850008595042Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2023-04-06
00850033976014Genesys HTA Control UnitMinerva Surgical, Inc.MNB2022-06-08
00850033976021Genesys HTA Control Unit - RefurbishedMinerva Surgical, Inc.MNB2022-06-08
00850033976038Genesys HTA ProCervaMinerva Surgical, Inc.MNB2022-06-08
15420045514294NovaSureHologic, Inc.MNB2021-07-02
15420045514300NovaSureHologic, Inc.MNB2021-07-02
25420045514307NovaSureHologic, Inc.MNB2021-07-02
00850008595028Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
20850008595022Exhaust Collection BagCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00850008595035Cerene Cryotherapy DeviceCHANNEL MEDSYSTEMS, INC.MNB2020-08-21
00857379006023Mara ConsoleAEGEA MEDICAL INC.MNB2020-03-16
00857379006030Mara Water Vapor Probe KitAEGEA MEDICAL INC.MNB2020-03-16
00862393000100Minerva RF ControllerMinerva Surgical, Inc.MNB2017-06-27
00862393000117Minerva Disposable HandpiecesMinerva Surgical, Inc.MNB2017-06-27
00862393000131Minerva Argon Gas Canister (5 pack)Minerva Surgical, Inc.MNB2017-06-27
00862393000148Minerva Co2 CanistersMinerva Surgical, Inc.MNB2017-06-27
00862393000155Minerva DesiccantMinerva Surgical, Inc.MNB2017-06-27
00862393000162Minerva Single Sterile Disposable HandpieceMinerva Surgical, Inc.MNB2017-06-27