The MyoSure® Manual Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.
Myosure Manual Tissue Removal Device - 20-401ML
Device Description
A hand-held component of a tissue morcellation system intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It consists of a high-speed rotating blade in a holder and is connected to a line-powered control unit for the transfer of electrical energy or rotational power (via an electrical or remote drive cable); a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually with a grasping instrument. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HIH
Device Name: Hysteroscope (And Accessories)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 884.1690
Third Party Flag: Y
Medical Specialty: OB
Device IdentifiersDevice Id: 15420045507937
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 35420045507931
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045507934
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 45420045507938
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 25420045507934
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 25420045507934
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045507937
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CARTON
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