DORO Lucent® Disposable Skull Pins

GUDID 04250435517789

DORO Lucent® Disposable Skull Pins, Adult (sterile, 3pcs)

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp

• Primary Device ID: 04250435517789
• NIH Device Record Key: 0b73ae31-d333-46b1-9a27-41d60d55fd71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO Lucent® Disposable Skull Pins
• Version Model Number: 1106.003
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250435517789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032331
• Premarket Notification: K191740

FDA Product Code

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

Sterilization

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

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 Lucent® Disposable Skull Pins]

• 04250435517796: DORO Lucent® Disposable Skull Pins, Adult, sterile, 9 pcs
• 04250435517789: DORO Lucent® Disposable Skull Pins, Adult (sterile, 3pcs)