AccessGUDID - DEVICE: EnSite™ (05415067033284)

GUDID

Device Identifier (DI) Information

Brand Name: EnSite™
Version or Model: ENSITE-PRSFRNT-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ENSITE-PRSFRNT-01
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067033284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Patient Reference Sensor

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?
43267	Patient positioning sensor	A device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, diagnostic, programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202066	000
K221213	000
K223094	000
K231415	000
K242016	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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Temperature: between -25 and 60 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54a8c1b1-86ff-4f19-9449-544e896954d9
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: January 06, 2021