ColpotomizOR Tube System

Basic Information

• Brand Name: ColpotomizOR Tube System
• Primary DI: 09349967003473
• Version / Model: CTS45-TV
• Company Name: THE O R COMPANY PTY LTD
• Labeler DUNS: 744346235
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-27
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: f4ee26ef-55e8-45f8-89cb-7ecaaa869add

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	884.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58051	Uterine manipulator, single-use	A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09349967003497	GS1	Shipper	3	In Commercial Distribution
Package	09349967003480	GS1	Outer	5	In Commercial Distribution
Primary	09349967003473	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	32	Millimeter