Summit X-ray Collimator D800

GUDID B307D8000

Collimator, manual, Radiographic (892-1610)

SUMMIT INDUSTRIES, LLC

Manual-aperture-control diagnostic x-ray system collimator, non-motorized

• Primary Device ID: B307D8000
• NIH Device Record Key: 2906f387-ea67-470f-bc94-f374290310dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit X-ray Collimator
• Version Model Number: D800
• Catalog Number: D800
• Company DUNS: 130235187
• Company Name: SUMMIT INDUSTRIES, LLC
• 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

Customer Support Contacts

• Phone: +1773-353-4000
• Email: villih@summitindustries.Net
• Phone: +1773-353-4000
• Email: villih@summitindustries.Net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net
• Phone: +17733534000
• Email: davidv@summitindustries.net

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B307D8000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874687

FDA Product Code

• IZX: Collimator, manual, radiographic

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: 2016-09-15

Devices Manufactured by SUMMIT INDUSTRIES, LLC

• B307D8000 - Summit X-ray Collimator: 2018-07-06Collimator, manual, Radiographic (892-1610)
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• B307A172F0 - Summit: 2018-03-29 RADIOGRAPHIC IMAGE RECEPTOR STAND
• B307C2560 - Summit Radiographic table: 2018-03-29 Table Radiologic, stationary top (892.1980)
• B307J10000 - Summit: 2018-03-29 RADIOGRAPHIC IMAGE RECEPTOR STAND
• B307J7000 - Summit: 2018-03-29 RADIOGRAPHIC TUBESTAND
• B307S1020 - Summit: 2018-03-29 RADIOGRAPHIC IMAGE RECEPTOR STAND
• B307S1050 - Summit: 2018-03-29 RADIOGRAPHIC TUBESTAND
• B307S1070 - Summit: 2018-03-29 RADIOGRAPHIC IMAGE RECEPTOR STAND