AccessGUDID - DEVICE: MyoSure Tissue Removal System Control Unit (15420045505124)

GUDID

Device Identifier (DI) Information

Brand Name: MyoSure Tissue Removal System Control Unit
Version or Model: 10-550
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-550
Company Name: Hologic, Inc.

Primary DI Number: 15420045505124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: The MyoSure®Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46729	Tissue morcellation system	An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	HYSTEROSCOPE (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152723	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -15 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 381 and 787 Millimeter of Mercury

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 10443041-f914-4cce-a97a-578efb08de6b
Public Version Date: August 07, 2023
Public Version Number: 4
DI Record Publish Date: May 19, 2016