DORO LUNA® Retractor System

GUDID 04250435519349

DORO LUNA® Retractor System - Standard System consisting of: 1203.001 1203.002 1203.003 1203.004 1203.006 1203.091 1201.091 3

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retraction system, reusable

• Primary Device ID: 04250435519349
• NIH Device Record Key: 2c2acf14-4cda-430d-baca-b0d976e9f52e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUNA® Retractor System
• Version Model Number: 1203.100
• 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	04250435519349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001808

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

[04250435519349]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-12-15

On-Brand Devices [DORO LUNA® Retractor System]

• 04250435519639: DORO LUNA® Compact Retractor System & DORO® QR3 Headrest System consisting of: 3116-151
• 04250435519622: DORO LUNA® Compact Retractor System & DORO® QR3 Skull Clamp consisting of: 3116-151 3116
• 04250435519615: DORO LUNA® Standard Retractor System & DORO® QR3 Headrest System cons
• 04250435519608: DORO LUNA® Standard Retractor System & DORO® QR3 Skull Clamp consisting
• 04250435519356: DORO LUNA® Retractor System - Compact System consisting of:
• 04250435519349: DORO LUNA® Retractor System - Standard System consisting of: 1203.001