Extended Worktop - Umbilical Carts 90-1044S

GUDID 00850309007411

ASI MEDICAL, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00850309007411
• NIH Device Record Key: e1eb6c77-888e-40a0-bb9b-0ee957588362
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extended Worktop - Umbilical Carts
• Version Model Number: 90-1044S
• Catalog Number: 90-1044S
• Company DUNS: 808695159
• Company Name: ASI MEDICAL, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850309007411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110481

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-02
• Device Publish Date: 2019-07-25

On-Brand Devices [Extended Worktop - Umbilical Carts]

• 00850309007466: 90-2044
• 00850309007442: 90-2044S
• 00850309007411: 90-1044S
• 00850309007473: 90-2042