DORO® CereTom®

GUDID 04250435521236

DORO® CereTom® RDL Extension Bars (185 mm) for Fixed Arm

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp

• Primary Device ID: 04250435521236
• NIH Device Record Key: 704ac196-1aff-4016-8ce8-cf6da28d85a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® CereTom®
• Version Model Number: 4003.304.002
• 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: 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	04250435521236 [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: 2016-12-16

On-Brand Devices [DORO® CereTom® ]

• 04250435521236: DORO® CereTom® RDL Extension Bars (185 mm) for Fixed Arm
• 04250435521229: DORO® CereTom® RDL Extension Bars (185 mm) for Extension Arm
• 04250435521212: DORO® CereTom® RDL Extension Bars (120 mm) for Fixed Arm
• 04250435521205: DORO® CereTom® RDL Extension Bars (120 mm) for Extension Arm
• 04250435521199: DORO® CereTom® RDL Extension Bars (150 mm) for Fixed Arm
• 04250435521182: DORO® CereTom® RDL Extension Bars (150 mm) for Extension Arm
• 04250435520956: DORO® CereTom® RDL Extension Bars (185 mm) for DORO® CereTom® In
• 04250435520949: DORO® CereTom® RDL Extension Bars (150 mm) for DORO® CereTom® In
• 04250435520932: DORO® CereTom® RDL Extension Bars (120 mm) for DORO® CereTom® In
• 04250435520840: DORO® CereTom® IntraOP QR3 Set (CT, X-Ray and Fluoroscopy) consisting of: 4002-10 4003.301 303