CompuDent STA Drive Unit

GUDID 00618874112042

STA Instrument 220V

Milestone Scientific Inc.

Electric infusion pump administration set, single-use

• Primary Device ID: 00618874112042
• NIH Device Record Key: 9bad3b97-2f4c-464c-bf47-4089bf504e05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompuDent STA Drive Unit
• Version Model Number: STA-5220
• Company DUNS: 006891188
• Company Name: Milestone Scientific 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618874112042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061904

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by Milestone Scientific Inc.

• 00618874601034 - CathCheck Disposable Kit (Pre-assembled): 2023-06-22 CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System
• 00618874601102 - Epidural Disposable Kit: 2023-06-22 Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
• 00618874610012 - Epidural Disposable Box: 2023-06-22 Epidural Disposable Box of 10 units
• 00618874610036 - CathCheck Disposable Kit: 2023-06-22 CathCheck Disposable Kit box of 10 units to be used with CompuFlo Epidural Computer Controlled Anesthesia System
• 00618874999988 - Epidural Trainer Disposable Kit: 2023-06-22 EPI 6510T CompuFlo Epidural Trainer Disposable Kit
• 00618874999995 - CompuFlo Epidural Trainer 110V/220V: 2023-06-22 CompuFlo Epidural Trainer
• 00618874112042 - CompuDent STA Drive Unit: 2023-06-21STA Instrument 220V
• 00618874112042 - CompuDent STA Drive Unit: 2023-06-21 STA Instrument 220V
• 00618874116033 - CompuFlo Epidural Computer Controlled Anesthesia System: 2023-06-21 CompuFlo Epidural Computer Controlled Anesthesia System 110V