DRYPRO SD-P

GUDID 64560141934797

MEDICAL IMAGING FILM

KONICA MINOLTA, INC.

Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen Medical x-ray film, non-screen

• Primary Device ID: 64560141934797
• NIH Device Record Key: 75497d98-29cc-4abd-9c9a-f3edb293a354
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRYPRO SD-P
• Version Model Number: A5FH
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 125
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	44560141934793 [Primary]
GS1	64560141934797 [Package]; Contains: 44560141934793; Package: Box [4 Units]; In Commercial Distribution
GS1	84560141934791 [Unit of Use]

FDA Product Code

• IWZ: Film, Radiographic

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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [DRYPRO SD-P]

• 64560141934858: MEDICAL IMAGING FILM
• 64560141934827: MEDICAL IMAGING FILM
• 64560141934803: MEDICAL IMAGING FILM
• 64560141934797: MEDICAL IMAGING FILM