AccessGUDID - DEVICE: SpineSTAR® (10884450488550)

GUDID

Device Identifier (DI) Information

Brand Name: SpineSTAR®
Version or Model: 10884450488550
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STR-0510L/B
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 10884450488550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 75
Labeler D-U-N-S® Number*: 184763290 *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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
64233	Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar	A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a bipolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes distal electrodes in a bipolar arrangement and may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

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
Device Size Text, specify: Gauge-11G
Device Size Text, specify: Length-17.5 cm
Device Size Text, specify: Size-Long

Device Record Status

Public Device Record Key: 566bdfc0-baf9-4860-abef-15242bbeb04d
Public Version Date: October 14, 2024
Public Version Number: 2
DI Record Publish Date: October 05, 2022