AccessGUDID - DEVICE: Sharn by Marketlab (00859290006489)

GUDID

Device Identifier (DI) Information

Brand Name: Sharn by Marketlab
Version or Model: Sharn SSP-400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRUER MEDICAL, INC.

Primary DI Number: 00859290006489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003530786 *Terms of Use

Device Description: The Sharn by Marketlab Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Sharn by Marketlab Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps.

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:	Yes
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?
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101244	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: 37f686c5-fd8e-4f23-b969-f776060ec565
Public Version Date: November 06, 2024
Public Version Number: 1
DI Record Publish Date: October 29, 2024