AccessGUDID - DEVICE: Medistim QuickFIT TTFM probe (07070554100726)

GUDID

Device Identifier (DI) Information

Brand Name: Medistim QuickFIT TTFM probe
Version or Model: PQ100041
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PQ100041
Company Name: Medistim ASA

Primary DI Number: 07070554100726
Issuing Agency: GS1
Commercial Distribution End Date: July 29, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 519521751 *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?
61226	Invasive vascular ultrasound system probe	A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992305	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Hydrogen Peroxide
Liquid Chemical
Ethylene Oxide

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: 32f476be-19d6-4eb2-bbf2-2fbe0afc41f4
Public Version Date: October 17, 2023
Public Version Number: 5
DI Record Publish Date: September 15, 2016