DORO® Quick-Clamp

GUDID 04250435506462

DORO® Quick-Clamp Halo Coupling Set consists of: 1202.014 1202.015 1202.016

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable

• Primary Device ID: 04250435506462
• NIH Device Record Key: 22ea024f-200c-4a2f-b821-9a4b0d427107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Quick-Clamp
• Version Model Number: 1202.010
• 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: 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	04250435506462 [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

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

[04250435506462]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-15

On-Brand Devices [DORO® Quick-Clamp]

• 04250435506653: DORO® Quick-Clamp J-Arm Coupling Set consisting of: 1202.014 1202.015
• 04250435506509: DORO® Quick-Clamp Coupling Universal
• 04250435506479: DORO® Quick-Clamp
• 04250435506462: DORO® Quick-Clamp Halo Coupling Set consists of: 1202.014 1202.015 1202.016
• 04250435506363: DORO® Quick-Clamp w/ Interface Mizuho-Type Retractors
• 04250435506301: DORO® Quick Clamp IGS Articulated Support Arm
• 04250435506288: DORO® Quick-Clamp Twin QR Coupling Set consisting of: 1201.010 1201.043