FMX FMRPM

GUDID 00859729006028

FMX Reusable Power Module

DOMAIN SURGICAL, INC.

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Primary Device ID	00859729006028
NIH Device Record Key	3cf70030-3ec2-4d79-be22-a23ac6fcc097
Commercial Distribution Status	In Commercial Distribution
Brand Name	FMX
Version Model Number	RPM
Catalog Number	FMRPM
Company DUNS	963249342
Company Name	DOMAIN SURGICAL, 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	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859729006028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K130606

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories