Oncology EDR2 Film 8097214

GUDID 60889978097210

Oncology EDR2 Film 10X12in RDYPK 50SH

CARESTREAM HEALTH, INC.

Medical x-ray film, non-screen

• Primary Device ID: 60889978097210
• NIH Device Record Key: 6e4661f1-6e22-4e3b-bad4-9b9aca60ccd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oncology EDR2 Film
• Version Model Number: Oncology EDR2 Film
• Catalog Number: 8097214
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 0
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 60 Percent (%) Relative Humidity and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 0
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Humidity: Between 60 Percent (%) Relative Humidity and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889978097218 [Unit of Use]
GS1	40889978097216 [Primary]
GS1	60889978097210 [Package]; Contains: 40889978097216; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• IWZ: Film, radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [Oncology EDR2 Film]

• 60889978097210: Oncology EDR2 Film 10X12in RDYPK 50SH
• 60889971161765: ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH