CARESTREAM CR Mammography Cassette with SNP-M1 Scr 1978600

GUDID 60889971978608

CARESTREAM CR Cassette 35x43 / 14x17

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic

• Primary Device ID: 60889971978608
• NIH Device Record Key: 3360be50-eebe-4511-a2fe-018402dc770e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESTREAM CR Mammography Cassette with SNP-M1 Scr
• Version Model Number: CARESTREAM CR Mammography Cassette with SNP-M1 Scr
• Catalog Number: 1978600
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971978608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120246

FDA Product Code

• MUE: Full field digital,system,x-ray,mammographic

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 [CARESTREAM CR Mammography Cassette with SNP-M1 Scr]

• 60889978215201: 24X30 CR MAMMO CASS W/SNP-M1 SCREEN
• 60889971978608: CARESTREAM CR Cassette 35x43 / 14x17
• 60889971941503: 18X24 CR MAMMO CASS W/SNP-M1 SCREEN