OPTIMAX 1170-9-8000

GUDID 04260502640029

Darkroom automated x-ray film processor

PROTEC GmbH & Co. KG

Darkroom automated x-ray film processor

• Primary Device ID: 04260502640029
• NIH Device Record Key: 1d7c9f70-f2ff-4ab4-939a-01ebfdc01a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMAX
• Version Model Number: 1170
• Catalog Number: 1170-9-8000
• Company DUNS: 314629130
• Company Name: PROTEC GmbH & Co. KG
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260502640029 [Primary]

FDA Product Code

• IXW: Processor, Radiographic-Film, Automatic

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: 2019-12-17
• Device Publish Date: 2016-10-28

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• 04260502640272 - PROGNOST XPE: 2020-12-23 Basic diagnostic x-ray system table, powered