SpineSTAR® 3192/B

GUDID 10884450488321

Merit Medical Systems, Inc.

Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar

Primary Device ID	10884450488321
NIH Device Record Key	d81fbd7f-b0a2-4d37-a14c-e30706201a87
Commercial Distribution Status	In Commercial Distribution
Brand Name	SpineSTAR®
Version Model Number	00884450488324
Catalog Number	3192/B
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450488324 [Primary]
GS1	10884450488321 [Package] Contains: 00884450488324 Package: [75 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K091310

FDA Product Code

GEI	Electrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-10-17
Device Publish Date	2022-10-07

On-Brand Devices [SpineSTAR®]

10884450296094	00884450296097
10884450296087	00884450296080
10884450296001	00884450296004
10884450296032	00884450296035
00884450488553	10884450488550
10884450488321	00884450488324
00884450488560	10884450488567

Trademark Results [SpineSTAR]

Mark Image Registration \| Serial	Company Trademark Application Date
SPINESTAR 86101109 not registered Dead/Abandoned	Kottalis, Lambros N 2013-10-24
SPINESTAR 85299171 4400569 Live/Registered	Dfine, Inc. 2011-04-19