IA-16LD/HS13

GUDID 04540217026135

SHIMADZU CORPORATION

X-ray image intensifier

• Primary Device ID: 04540217026135
• NIH Device Record Key: 493f77b6-fc92-4e1e-b3ad-bcaddf8c9e0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IA-16LD/HS13
• Version Model Number: 532-16728-65
• Company DUNS: 690558747
• Company Name: SHIMADZU CORPORATION
• 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: true
• 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	04540217026135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012424

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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 [IA-16LD/HS13]

• 04540217026135: 532-16728-65
• 04540217020249: 532-16728-15