Precision CRF

GUDID 00884838110588

The Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes - Additional Detector battery charger - Adjustable Straps for Patient Support - Additional Battery for SkyPlate - Ankle Clamps - Arm Support - Compression Belt (singles. pull) - Detector and grid storage - Detector Holder for Patient Bed - Footrest 800 - Hand grips (Pair of) - Handle for portable Detector - Infusion bottle holder - Leg Supports (Pair of) - Table Mattress - Monitor Ceiling Suspension for 1 Monitor - Monitor Ceiling Suspension for 2 Monitors - Monitor Ceiling Suspension for 3 Monitors - Monitor Trolley for 1 Monitor assembly - Monitor Trolley for 2 Monitors assembly - Overhead Handgrip - Parking frame for accessories - Patient Support for Stitching - Rotatable stool for footrest - Set of 50 Hygienic Bags large - Shoulder supports (Pair of) - Side Bar - Skyplate cable and holder pack - Protector Large Cass. Size Det - Stretch Grip for VS/VM Stand - Adjustable lateral cassette holder - Barcode reader

Philips Medical Systems DMC GmbH

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• Primary Device ID: 00884838110588
• NIH Device Record Key: 29f5f9be-bc4e-4786-8516-15c31bac91d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision CRF
• Version Model Number: 706400
• Company DUNS: 314101218
• Company Name: Philips Medical Systems DMC GmbH
• 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	00884838110588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212837

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-22
• Device Publish Date: 2023-02-14

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