BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

VersaStep

DI: 10884521080959 · Model: VSR100712 · Covidien LP

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: VersaStep
Primary DI: 10884521080959
Version / Model: VSR100712
Catalog Number: VSR100712
Company Name: Covidien LP
Labeler DUNS: 058614483
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-24
Public Version: 7
Public Version Date: 2025-06-24
Public Version Status: Update
Public Device Record Key: f885b4c0-337d-421a-9d33-8b60e09c9f10
Distribution End Date: 2019-10-02

Device Description

Reposable Dilator

Device Characteristics

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

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37151	Laparoscopic access cannula dilator	A hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521080959	GS1

Customer Contacts

Phone: +1(508)261-8000
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K012539	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	12	Millimeter
Device Size Text, specify			Length,Short,N/A;