AccessGUDID - DEVICE: Spectros T-Stat (00851136007018)

GUDID

Device Identifier (DI) Information

Brand Name: Spectros T-Stat
Version or Model: CTH-060-SUR 1cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPECTROS CORPORATION

Primary DI Number: 00851136007018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929856680 *Terms of Use

Device Description: 1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.

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?
46618	Tissue saturation oximeter sensor, single-use	A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUD	Oximeter, Tissue Saturation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081233	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 7ed9b1e3-a387-48de-9a3b-5d23c3255dbd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 17, 2016