DORO COBRA® Retractor System

GUDID 04250435527009

DORO COBRA® Retractor System consists of: 1201.021 1201.007 3116-111 3116-121 3116-131 3116-141 3116-151 1201.091

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable Surgical retractor/retraction system blade, reusable

• Primary Device ID: 04250435527009
• NIH Device Record Key: e4bda0af-ee66-4d94-afd2-637e8dccf8c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO COBRA® Retractor System
• Version Model Number: 1201.020
• Company DUNS: 313517922
• Company Name: pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	04250435527009 [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

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

Moist Heat or Steam Sterilization

[04250435527009]

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

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