VCM 50

Basic Information

• Brand Name: VCM 50
• Primary DI: 00856589007059
• Version / Model: VCM-50
• Company Name: KRONNER PROTOTYPES, INCORPORATED
• Labeler DUNS: 091301184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c118b2da-f6ac-4d5f-8666-002fe282e5da

Device Description

For supporting the vagina during laparoscopic vaginal procedures. 50 mm width, inserted end.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDL	Retractor, Vaginal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13392	Vaginal retractor, self-retaining	A self-locking, surgical instrument, used for separating the edges of the vagina and holding back the tissue allowing a surgical intervention or examination. The instrument may resemble a large pair of scissors or have an open circle design with pointed, blunted, or wire-like blades or claws that grasp and part the tissue of the vaginal opening. It is typically made of stainless steel and comes in a variety of designs. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856589007059	GS1