ColpoWave Balloon

Basic Information

• Brand Name: ColpoWave Balloon
• Primary DI: 09351599000119
• Version / Model: CBD
• Company Name: SURGITOOLS PTY. LTD.
• Labeler DUNS: 745798822
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8227fbeb-951d-4163-999a-f700914ca81a

Device Description

ColpoWave Balloon blister pack containing one sterile unit

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
47936	Colpotomy tube	A sterile, hand-held, hollow cylindrical device designed to facilitate dissection of the cervical/vaginal junction during total laparoscopic-assisted hysterectomy. It is typically made of plastic material and functions as a transvaginal conduit for surgical instruments and as an anvil-like support during dissection. Its distal end is designed to fit tightly against the cervix, and its proximal end has a seal to prevent loss of peritoneum-distention gas [e.g., carbon dioxide (CO2)] used during the laparoscopic procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09351599000119	GS1

Premarket Submissions

Submission Number	Supplement Number
K161065	000