IA-16LM(6)/HS12

GUDID 04540217026081

SHIMADZU CORPORATION

X-ray image intensifier

• Primary Device ID: 04540217026081
• NIH Device Record Key: 0a3bd1df-d7ea-4613-826a-7df1505cef78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IA-16LM(6)/HS12
• Version Model Number: 532-16726-62
• 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	04540217026081 [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-16LM(6)/HS12]

• 04540217026081: 532-16726-62
• 04540217020171: 532-16726-12