N/A 90-1045

GUDID 00850309007015

Classic Assistant's System

ASI MEDICAL, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00850309007015
• NIH Device Record Key: c68e0644-d3b5-465a-9ad7-3f15b54c29a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 90-1045
• Catalog Number: 90-1045
• Company DUNS: 808695159
• Company Name: ASI MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850309007015 [Primary]

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-31

On-Brand Devices [N/A]

• 00850309007053: Designer Dental System
• 00850309007046: Designer Assistant's System
• 00850309007039: Designer Assistant's System
• 00850309007022: Classic Dental System
• 00850309007015: Classic Assistant's System
• 00850309007008: Classic Assistant's System