Resectr Resection Device 5FR (1.65 mm) M0065907051

GUDID 00850033976144

Resectr Tissue Resection Device 5FR (1.65 mm) (1) Vacuum Tube Adapter

Minerva Surgical, Inc.

Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device Hysteroscopic resection device
Primary Device ID00850033976144
NIH Device Record Key1338732c-35c1-40ed-bc97-871fa3bd244d
Commercial Distribution StatusIn Commercial Distribution
Brand NameResectr Resection Device 5FR (1.65 mm)
Version Model NumberM0065907051
Catalog NumberM0065907051
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter
Catheter Gauge5 French
Outer Diameter1.65 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033976144 [Primary]
GS108714729964537 [Previous]

FDA Product Code

HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-11
Device Publish Date2022-05-03

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 Unit2022-06-16 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.