D-Speed 1051267

GUDID 60889971051264

D-Speed 100 PKT 30.5X40.5MM FILM

CARESTREAM HEALTH, INC.

Dental x-ray film, non-screen

• Primary Device ID: 60889971051264
• NIH Device Record Key: e59a751b-e6c7-45b7-8ecc-73d86991a63f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Speed
• Version Model Number: D-Speed
• Catalog Number: 1051267
• 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 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889971051262 [Unit of Use]
GS1	40889971051260 [Primary]
GS1	60889971051264 [Package]; Contains: 40889971051260; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-19
• Device Publish Date: 2022-01-11

On-Brand Devices [D-Speed]

• 60889971051264: D-Speed 100 PKT 30.5X40.5MM FILM
• 00889978626487: 100PKT FLASH D-SPEED PERFECT FLM SIZE2