AccessGUDID - DEVICE: VELYS Hip Navigation (10603295532040)

GUDID

Device Identifier (DI) Information

Brand Name: VELYS Hip Navigation
Version or Model: 451580052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 451580052
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295532040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: VELYS Hip Navigation for iOS

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):	No
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?
45200	Orthopaedic stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument
LLZ	System, image processing, radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160284	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
No Device Sizes

Device Record Status

Public Device Record Key: f954acb8-4978-41e0-8aca-8de4ada11749
Public Version Date: August 09, 2021
Public Version Number: 1
DI Record Publish Date: July 30, 2021