FUJI MEDICAL DRY FILM 4741008055

GUDID 14547410080558

MEDICAL DRY IMAGING FILM 100NIF 35x43

FUJIFILM CORPORATION

Diagnostic-imaging multiformat camera

• Primary Device ID: 14547410080558
• NIH Device Record Key: 26e4b699-fa1a-4f3d-8e0a-723fd52afe78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUJI MEDICAL DRY FILM
• Version Model Number: DI-AT 35X43 100
• Catalog Number: 4741008055
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: +018002728474
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx
• Phone: (800)272-8465
• Email: xxx@xxx.xxx

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410080551 [Primary]
GS1	14547410080558 [Package]; Contains: 04547410080551; Package: box [5 Units]; In Commercial Distribution
GS1	84547410080557 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033377
• Premarket Notification: K962967

FDA Product Code

• LMC: Camera, multi format, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [FUJI MEDICAL DRY FILM]

• 14547410265986: MEDICAL DRY IMAGING FILM 150NIF 20x25
• 14547410265962: MEDICAL DRY IMAGING FILM 150NIF 25x30
• 14547410222576: MEDICAL DRY IMAGING FILM 100NIF 35x43
• 14547410222569: MEDICAL DRY IMAGING FILM 150NIF 20x25
• 14547410222552: MEDICAL DRY IMAGING FILM 150NIF 25x30
• 14547410222545: MEDICAL DRY IMAGING FILM 150NIF 26x36
• 14547410222491: MEDICAL DRY IMAGING FILM 100NIF 35x43
• 14547410142454: MEDICAL DRY IMAGING FILM 100NIF 35x43
• 14547410142430: MEDICAL DRY IMAGING FILM 150NIF 26x36
• 14547410080794: MEDICAL DRY IMAGING FILM 100NIF 35x43
• 14547410080770: MEDICAL DRY IMAGING FILM 100NIF 26x36
• 14547410080558: MEDICAL DRY IMAGING FILM 100NIF 35x43
• 14547410080527: MEDICAL DRY IMAGING FILM 100NIF 20x25