MyoSure Tissue Removal Device

Basic Information

• Brand Name: MyoSure Tissue Removal Device
• Primary DI: 25420045505107
• Version / Model: 40-902
• Catalog Number: 40-902
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 4
• Public Version Date: 2023-08-08
• Public Version Status: Update
• Public Device Record Key: d411ccd1-0b5a-4820-9881-431be3c8f594

Device Description

MyoSure Single Use Seals are an accessory to the Hologic Hysteroscopes and are used to prevent distension fluid leakage from the proximal ends of hysteroscope and removable outflow channel.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIH	HYSTEROSCOPE (AND ACCESSORIES)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60650	Endoscope working-channel seal	A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	25420045505107	GS1
Unit of Use	15420045505100	GS1

Premarket Submissions

Submission Number	Supplement Number
K142029	000