APEX 6000214-5

GUDID 00858480006155

DOUBLE CEILING MOUNT (8FT.)

BURTON MEDICAL PRODUCTS CORPORATION

Operating light system

• Primary Device ID: 00858480006155
• NIH Device Record Key: b238878d-de2d-4fc5-92d3-0580ce0cf349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX
• Version Model Number: APDC8
• Catalog Number: 6000214-5
• 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	00858480006155 [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