DIRECTVIEW CR Cassette with PQ Screen 1933985

GUDID 60889971933980

10SC 35X35CM DIRECTVIEW PQ SCR

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen

• Primary Device ID: 60889971933980
• NIH Device Record Key: f437a2b2-9d95-4e54-a064-17051d8b87cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Cassette with PQ Screen
• Version Model Number: DIRECTVIEW CR Cassette with PQ Screen
• Catalog Number: 1933985
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 10
• 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: false
• 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 Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00088997193398 [Unit of Use]
GS1	60889971933980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040378

FDA Product Code

• IXA: Cassette, radiographic film

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [DIRECTVIEW CR Cassette with PQ Screen]

• 60889978933884: SGL 35X35CM DIRECTVIEW PQ SCR
• 60889978824601: 35x43CM DV CR REPLACMT PLATE/PQ SCR
• 60889978619108: 10SC 35X43CM DIRECTVIEW PQ SCR
• 60889978604500: 15X30CM DIRECTVIEW PQ SCR
• 60889978448760: SGL 24X30CM DIRECTVIEW PQ SCR
• 60889978294459: 24x30CM DV CR REPLACMT PLATE/PQ SCR
• 60889978104147: 15x30CM DV CR REPLACMT PLATE/PQ SCR
• 60889971933980: 10SC 35X35CM DIRECTVIEW PQ SCR
• 60889971831989: SGL 18X24CM DIRECTVIEW PQ SCR
• 60889971827296: 18x24CM DV CR REPLACMT PLATE/PQ SCR
• 60889971640987: 35x35CM DV CR REPLACMT PLATE/PQ SCR
• 60889971603241: 35X43CM CR CASS/PQ/RIGID 100MICRON
• 60889971600004: 10SC 24X30CM DIRECTVIEW PQ SCR
• 60889971433701: 10SC 15X30CM DIRECTVIEW PQ SCR
• 60889971157539: 10SC 18X24CM DIRECTVIEW PQ SCR
• 60889971089410: SGL 35X43CM DIRECTVIEW PQ SCR
• 60889971031761: 35X35CM CR CASS/PQ/RIGID 100MICRON
• 60889978413515: DIRECTVIEW CR Cassett with PQ Scrn 35x43