AIM 200 4000104

GUDID 00858480006209

SPRING ARM

BURTON MEDICAL PRODUCTS CORPORATION

Operating light system

• Primary Device ID: 00858480006209
• NIH Device Record Key: d78e5812-7bea-4a61-a585-be81d18c8afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIM 200
• Version Model Number: SLW-068055-3WG
• Catalog Number: 4000104
• 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	00858480006209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101537

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 [AIM 200]

• 00858480006209: SPRING ARM
• 00858480006100: WALL MOUNT
• 00858480006094: SINGLE CEILING MOUNT
• 00858480006087: FLOOR BASE ASSEMBLY
• 00858480006070: DOUBLE CEILING MOUNT
• 00858480006063: LIGHT HEAD