AccessGUDID - DEVICE: VersaStep (10884521080980)

GUDID

Device Identifier (DI) Information

Brand Name: VersaStep
Version or Model: VSR101008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VSR101008
Company Name: Covidien LP

Primary DI Number: 10884521080980
Issuing Agency: GS1
Commercial Distribution End Date: October 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Reusable Dilator

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:	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012539	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 7cdc7232-2338-44ec-96ea-6aa3e3f2fdf3
Public Version Date: June 24, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016