AccessGUDID - DEVICE: OmniSight™ (00889024596061)

GUDID

Device Identifier (DI) Information

Brand Name: OmniSight™
Version or Model: OMST1050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OMST1050
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024596061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: No description.

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?
64496	Touchscreen	An electrically-powered visual display unit (VDU) designed as an output device for displaying data (e.g., patient images, videos) and as an input device to enable interactive manipulation of the data by the operator through touches to the display screen. It is intended to be connected to a computer or a medical device (i.e., the screen has no computing capabilities); it may be used to control a medical device (e.g., operating room lights) depending on parent device software. It is typically a portable or mounted liquid crystal display (LCD) or light-emitting diode (LED) unit, and may include an antimicrobial material to prevent cross-contamination in a medical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical device data system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 50.00 Inch

Device Record Status

Public Device Record Key: f9f886af-456f-4b6f-97cd-2d441759fc35
Public Version Date: October 24, 2022
Public Version Number: 3
DI Record Publish Date: July 23, 2021