DORO LUNA® Retractor System

GUDID 04250435519639

DORO LUNA® Compact Retractor System & DORO® QR3 Headrest System consisting of: 3116-151 3116-141 3116-131 3116-121 3116-111 1201.091 1203.091 12

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

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Primary Device ID	04250435519639
NIH Device Record Key	a2484304-a67c-46d8-94ad-215ccdf37ab6
Commercial Distribution Status	In Commercial Distribution
Brand Name	DORO LUNA® Retractor System
Version Model Number	1203.220
Company DUNS	313517922
Company Name	pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
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	04250435519639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K001808

FDA Product Code

HBL	Holder, Head, Neurosurgical (Skull Clamp)