CR Cassettes for Vita Systems 8002685

GUDID 60889978002689

VITA CR DENTAL PANORAMIC PACKAGE

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray

• Primary Device ID: 60889978002689
• NIH Device Record Key: b20fa762-1fe7-4180-9b9f-77ff57ce0f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR Cassettes for Vita Systems
• Version Model Number: CR Cassettes for Vita Systems
• Catalog Number: 8002685
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889978002689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945039

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 [CR Cassettes for Vita Systems]

• 60889978964390: CARESTREAM CR Cassette 25x30/10x12
• 60889978719662: 35X35CM CR CASSETTE GP PLUS
• 60889978427772: CARESTREAM CR Cassette 20x25 / 8x10
• 60889978216369: CARESTREAM CR Cassette 28x35 / 11x14
• 60889978041978: P-O-C 120/140 DENTAL PAN PKG, GP2
• 60889978002689: VITA CR DENTAL PANORAMIC PACKAGE
• 60889971696830: CARESTREAM CR Cassette 35x83/14x33
• 60889971627582: CARESTREAM CR Cassette 15x30 cm
• 60889971282682: CARESTREAM CR Cassette 24x30 cm
• 60889971033741: CARESTREAM CR CASS W SCRN 8X10IN
• 60889971033734: CARESTREAM CR CASS W SCRN 10X12IN
• 60889971033727: CARESTREAM CR CASS W SCRN 14X17IN