AccessGUDID - DEVICE: VersaStep (10884521080928)

GUDID

Device Identifier (DI) Information

Brand Name: VersaStep
Version or Model: VSR100705
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521080928
Issuing Agency: GS1
Commercial Distribution End Date: January 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Reposable 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
Handling Environment Temperature: less than 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length,Short,N/A;
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 40aa9e13-5ebc-49bf-a1f3-9b2b5e926113
Public Version Date: June 24, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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