AIM 100 1017067-2

GUDID 00858480006056

WALL MOUNT

BURTON MEDICAL PRODUCTS CORPORATION

Operating light system

• Primary Device ID: 00858480006056
• NIH Device Record Key: e5bc3d5b-e044-40dd-81fd-fea330f2fb08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIM 100
• Version Model Number: A100W
• Catalog Number: 1017067-2
• 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	00858480006056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042395

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 100]

• 00858480006261: WALL MOUNT
• 00858480006254: SINGLE CEILING MOUNT
• 00858480006247: FLOOR BASE ASSEMBLY
• 00858480006230: DOUBLE CEILING MOUNT
• 00858480006223: LIGHT HEAD
• 00858480006056: WALL MOUNT
• 00858480006049: FLOOR BASE ASSEMBLY
• 00858480006032: SPRING ARM ASSEMBLY
• 00858480006025: DOUBLE CEILING MOUNT
• 00858480006018: SINGLE CEILING MOUNT
• 00858480006001: LIGHT HEAD