X-ray Beam Filter Kit 8154114

GUDID 60889978154111

4X4 X-ray Beam Filter Kit

CARESTREAM HEALTH, INC.

X-ray/radiation therapy beam filter, sheet X-ray/radiation therapy beam filter, sheet

• Primary Device ID: 60889978154111
• NIH Device Record Key: c20fd719-97e0-4391-8c66-78c3b33264b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray Beam Filter Kit
• Version Model Number: X-ray Beam Filter Kit
• Catalog Number: 8154114
• 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	40889978154117 [Primary]
GS1	60889978154111 [Package]; Contains: 40889978154117; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K837334

FDA Product Code

• KPW: Device, beam limiting, x-ray, diagnostic

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

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