Genesys HTA Scope Adapter, OLYMPUS M006550360

GUDID 00850033976199

OLYMPUS Scope Adapter, for use only with Genesys HTA System

Minerva Surgical, Inc.

Endoscope sheath, reusable
Primary Device ID00850033976199
NIH Device Record Keyfbd377f1-0b08-41f9-8ea1-9d231a307aac
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesys HTA Scope Adapter, OLYMPUS
Version Model NumberM006550360
Catalog NumberM006550360
Company DUNS829616478
Company NameMinerva Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033976199 [Primary]
GS108714729469797 [Previous]

FDA Product Code

NWWHysteroscope Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


[00850033976199]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-27
Device Publish Date2022-10-19

Devices Manufactured by Minerva Surgical, Inc.

00850033976250 - HERizon Medical Endoscope Image Processor 2024-10-15 Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope.
10850033976264 - HERizon Disposable Electronic Hysteroscope2024-10-15 Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor
10850033976271 - HERizon Disposable Endoscopic Forceps - Biopsy2024-10-15 Disposable Endoscopic Forceps - Biopsy
10850033976288 - HERizon Disposable Endoscopic Forceps - Foreign Body Grasper2024-10-15 Disposable Endoscopic Forceps - Foreign Body Grasper
10850033976295 - HERizon Disposable Endoscopic Forceps – Alligator 2024-10-15 Disposable Endoscopic Forceps – Alligator
10850033976301 - HERizon Disposable Endoscopic Forceps - Inverted Tooth2024-10-15 Disposable Endoscopic Forceps - Inverted Tooth
10850033976318 - HERizon Disposable Endoscopic Scissors2024-10-15 Disposable Endoscopic Scissors
00850033976236 - INFINITY Fluid Management Accessory2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.