Horizon W

GUDID 15420045505834

Hologic, Inc.

Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy

• Primary Device ID: 15420045505834
• NIH Device Record Key: 465419c5-b46b-45eb-8ff6-db12b43a8412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Horizon W
• Version Model Number: Horizon W
• Company DUNS: 153623137
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045505834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023398

FDA Product Code

• KGI: Densitometer, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-01
• Device Publish Date: 2016-08-23

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