DIRECTVIEW CR Long-Length Cassette with PQ Screen 8754145

GUDID 60889978754144

CR LONG LENGTH PORTABLE CASS W/PQ

CARESTREAM HEALTH, INC.

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• Primary Device ID: 60889978754144
• NIH Device Record Key: e22d5714-4b6f-4761-be70-b9263d38021b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Long-Length Cassette with PQ Screen
• Version Model Number: DIRECTVIEW CR Long-Length Cassette with PQ Screen
• Catalog Number: 8754145
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889978754144 [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 Long-Length Cassette with PQ Screen]

• 60889978754144: CR LONG LENGTH PORTABLE CASS W/PQ
• 60889978010035: DV CR LONG-LENGTH CASS PKG W/ PQ
• 60889971033574: CR LLI W/PQ SCREEN