AccessGUDID - DEVICE: Symphion 6.3 Hysteroscope

GUDID

Device Identifier (DI) Information

Brand Name: Symphion 6.3 Hysteroscope - Refurbished
Version or Model: FG-0703-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-0703-R
Company Name: Minerva Surgical, Inc.

Primary DI Number: 00850033976137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829616478 *Terms of Use
Previous DI: 08714729905806

Device Description: Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller - Refurbished Contents: (1) Hysteroscope (1) Storz Scope Adapter (1) Wolf Scope Adapter (1) Working Channel Brush (1) Fluid Channel Brush

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:	Yes
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?
36628	Rigid optical hysteroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	Hysteroscope (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6.3 mm Diameter

Device Record Status

Public Device Record Key: 5d3d678d-73b3-4548-92c7-a3dc9b1626c1
Public Version Date: November 17, 2023
Public Version Number: 2
DI Record Publish Date: May 03, 2022