AccessGUDID - DEVICE: FullFire® Select Diffusing Tip Laser Probe (00816589020755)

GUDID

Device Identifier (DI) Information

Brand Name: FullFire® Select Diffusing Tip Laser Probe
Version or Model: 20624-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FFS002-01
Company Name: MONTERIS MEDICAL INC

Primary DI Number: 00816589020755
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 021415875 *Terms of Use

Device Description: 2.2mm Diffusing Tip Laser Probe

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
62268	MRI-guided laser interstitial thermal therapy system beam guide	A sterile, invasive, probe-like device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to direct and deliver laser energy for ablation of soft-tissue brain lesions. It is stereotactically placed by a neurosurgeon, using minimally-invasive techniques, and is manoeuvred during laser therapy by a remotely-controlled robotic arm/driver. It typically consists of fibreoptic materials with a laser-firing distal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

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

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
Outer Diameter: 2.2 Millimeter
Device Size Text, specify: Size 00

Device Record Status

Public Device Record Key: 0f7ab577-e96d-4f70-960f-3c536582b537
Public Version Date: October 18, 2018
Public Version Number: 3
DI Record Publish Date: October 25, 2017