DORO® Sterilization Case

GUDID 04250435503690

DORO® J-Arm Sterilization Case with Rack

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

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• Primary Device ID: 04250435503690
• NIH Device Record Key: 3af6001a-e629-4c1f-91ab-19cfced4ee56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Sterilization Case
• Version Model Number: 3214-00
• 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: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	04250435503690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032331

FDA Product Code

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

Sterilization

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

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® Sterilization Case]

• 04250435503690: DORO® J-Arm Sterilization Case with Rack
• 04250435502938: DORO® Quick-Rail Sterilization Case (w. Rack)