Genesys HTA Control Unit M006580010

GUDID 00850033976014

Genesys HTA 115V Control Unit

Minerva Surgical, Inc.

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Primary Device ID00850033976014
NIH Device Record Key5c370c16-9acd-406a-804a-af458606faa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesys HTA Control Unit
Version Model NumberM006580010
Catalog NumberM006580010
Company DUNS829616478
Company NameMinerva Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033976014 [Primary]
GS108714729809326 [Previous]

FDA Product Code

MNBDevice, Thermal Ablation, Endometrial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-16
Device Publish Date2022-06-08

Devices Manufactured by Minerva Surgical, Inc.

00850033976168 - Genesys HTA Scope Adapter, STORZ2022-10-27 STORZ Scope Adapter, for use only with Genesys HTA System
00850033976175 - Genesys HTA Scope Adapter, WOLF2022-10-27 WOLF Scope Adapter, for use only with Genesys HTA System
00850033976182 - Genesys HTA Scope Adapter, ACMI2022-10-27 ACMI Scope Adapter, for use only with Genesys HTA System
00850033976199 - Genesys HTA Scope Adapter, OLYMPUS2022-10-27 OLYMPUS Scope Adapter, for use only with Genesys HTA System
00850033976014 - Genesys HTA Control Unit2022-06-16Genesys HTA 115V Control Unit
00850033976014 - Genesys HTA Control Unit2022-06-16 Genesys HTA 115V Control Unit
00850033976021 - Genesys HTA Control Unit - Refurbished2022-06-16 Genesys HTA 115V Control Unit (Refurbished)
00850033976038 - Genesys HTA ProCerva2022-06-16 Procedure Set including Procedure Sheath, Cassette, Drainage Bag
00850033976205 - Genesys HTA System Pedestal2022-06-16 IV Pole, Tool Kit

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