DIRECTVIEW CR Mammography Cassette with EHR-M Scre 8611618

GUDID 60889978611614

24X30CM DV REPLCMT PLATE/EHR-M2 SCR

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen, mammographic

• Primary Device ID: 60889978611614
• NIH Device Record Key: 3566b515-52aa-43df-ad2e-b36dbc4b6676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Mammography Cassette with EHR-M Scre
• Version Model Number: DIRECTVIEW CR Mammography Cassette with EHR-M Scre
• Catalog Number: 8611618
• 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: true
• 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	60889978611614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080018

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 [DIRECTVIEW CR Mammography Cassette with EHR-M Scre]

• 60889978611614: 24X30CM DV REPLCMT PLATE/EHR-M2 SCR
• 60889978463329: 18X24CM DV REPLCMT PLATE/EHR-M2 SCR
• 60889978359158: 24X30CM DVIEW CR MAMMO SCR EHR-M2
• 60889978346134: 24X30CM DVIEW CR MAMMO SCR EHR-M
• 60889978792122: DIRECTVW CR Mammo Cass EHR-M Scrn 24x30
• 60889978188345: 18X24CM DVIEW CR MAMMO SCR EHR-M
• 60889971667571: DIRECTVW CR Mammo Cass EHR-M2 Scrn 24x30
• 60889971508270: DIRECTVW CR Mammo Cass EHR-M Scrn 18x24
• 60889971342867: 18X24CM DVIEW CR MAMMO SCR EHR-M2
• 60889971290380: DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24