APEX 6000194

GUDID 00858480006117

LIGHT HEAD

BURTON MEDICAL PRODUCTS CORPORATION

Operating light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system

• Primary Device ID: 00858480006117
• NIH Device Record Key: c929d449-0edb-4cf9-92fb-1516aee3cedf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX
• Version Model Number: APEX
• Catalog Number: 6000194
• Company DUNS: 022382667
• Company Name: BURTON MEDICAL PRODUCTS 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: true
• 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	00858480006117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963682

FDA Product Code

• FSY: Light, Surgical, Ceiling Mounted

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: 2016-06-24

On-Brand Devices [APEX]

• 00858480006162: DOUBLE CEILING MOUNT (10FT.)
• 00858480006155: DOUBLE CEILING MOUNT (8FT.)
• 00858480006148: SINGLE CEILING MOUNT (10FT.)
• 00858480006124: SINGLE CEILING MOUNT (8FT.)
• 00858480006117: LIGHT HEAD