Ultra-speed 1717131

GUDID 60889971717139

Ultra-speed 100PKT 30.5x40.5 film DF58C

CARESTREAM HEALTH, INC.

Dental x-ray film, non-screen

• Primary Device ID: 60889971717139
• NIH Device Record Key: 8559c60c-d7a1-402e-9842-427c8f63383c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-speed
• Version Model Number: Ultra-speed
• Catalog Number: 1717131
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 100
• 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: 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

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 0
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 0
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889971717137 [Unit of Use]
GS1	40889971717135 [Primary]
GS1	60889971717139 [Package]; Contains: 40889971717135; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• IWZ: Film, 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

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• 60889971753663: Ultra-speed 130PKT 30.5x40.5 film DF57
• 60889971717139: Ultra-speed 100PKT 30.5x40.5 film DF58C
• 60889971666161: Ultra-speed 25PKT 57x76 film DF50
• 60889971666123: Ultra-speed 25PKT 57x76 film DF49
• 60889971658197: Ultra-speed 150PKT 30.5x40.5 film DF58
• 60889971491756: Ultra-speed 150PKT 30.5x40.5 film DF57
• 60889971491732: Ultra-speed 150PKT 30.5x40.5 film DF58
• 60889971445360: Ultra-speed 75PKT 22x35 film DF54C
• 60889971296771: Ultra-speed 100PKT 27x54 film DF42 3BW
• 60889971273741: Ultra-speed 100PKT 24x40 film DF56
• 60889971273727: Ultra-speed 100PKT 24x40 film DF55
• 60889971228932: Ultra-speed 100PKT 22x35 film DF53
• 60889971228840: Ultra-speed 100PKT 22x35 film DF54
• 60889978818891: ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L