FDA.reportPublic FDA data

Minerva Hegar Dilator (3 Pack)

Primary DI
00862393000179
Brand
Minerva Hegar Dilator (3 Pack)
Company
Minerva Surgical, Inc.
Model
MIN8MM
Catalog number
MIN8MM
Device description
Minerva Hegar Dilator (3 Pack)
Published
2017-06-27
Public version status
Update
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
HDQDilator, Cervical, Fixed Size
MNBDevice, Thermal Ablation, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1
MNBDevice, Thermal Ablation, EndometrialUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862393000179PrimaryGS10
10862393000176Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862393000179008623930001798623930001790862393000179
1086239300017610862393000176

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced endoscopic electrosurgical submucosal lift/resection instrumentA flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of argon (Ar) gas (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by argon plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to the appropriate parent devices (i.e., argon-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include any controls. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-546-7874customerservice@minervasurgical.com
855-646-7874customerservice@minervasurgical.com

Regulatory Flags#

DUNS number
829616478
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033976373HERizon Vista ViewPoint Endoscopic Video Image ProcessorJY-MIP-3000JY-MIP-30002026-04-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894432434BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432441BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
04719894432458BiotequeBioteque Taiwan Ltd.HDQ2024-04-08
G586NSGU40600160Novo SurgicalNOVO SURGICAL, INC.HDQ2024-03-08
GYNX42111GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42121GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42131GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42211GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42221GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42231GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42401GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42451GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42501GynexGYNEX CORPORATIONHDQ2023-12-19
GYNX42551GynexGYNEX CORPORATIONHDQ2023-12-19
08800142923982V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924019V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924040V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924071V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924101V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
08800142924132V-GuideRF Medical Co.,Ltd.HDQ2023-10-25
07898506815050QuinelatoSchobell Industrial LtdaHDQ2023-01-09
07899798202634SchobellSchobell Industrial LtdaHDQ2023-01-09
10381780509363Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780509370Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-10-23
10381780500728Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500735Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500742Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500759Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500766Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18
10381780500773Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDQ2018-09-18