FDA.reportPublic FDA data

HERizon Disposable Endoscopic Scissors

Primary DI
10850033976318
Brand
HERizon Disposable Endoscopic Scissors
Company
Minerva Surgical, Inc.
Model
JY-JD-17-350-B
Catalog number
JY-JD-17-350-B
Device description
Disposable Endoscopic Scissors
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWWHysteroscope Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850033976318PackageGS110In Commercial Distribution
20850033976315PackageGS19In Commercial Distribution
00850033976311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003397631810850033976318
2085003397631520850033976315
00850033976311008500339763118500339763110850033976311

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic scissors, single-useA sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829616478
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06974880994343Omni® Hysteroscopic GrasperSuzhou AcuVu medical technology Co., Ltd.NWW2026-04-17
00190776420208MillenniumAvalign Technologies, Inc.NWW2026-04-16
05708265017881LiNA OperaScope™ Lasso LiNA Medical AGNWW2026-04-03
05708265017904LiNA OperaScopeTM LassoLiNA Medical AGNWW2026-04-03
05708265017928LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
00850033976359HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
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