Mystro MY3015

GUDID 00817428021391

MY3015, Aspiration Needle, 5mm x 42cm, 15 Gauge Needle, 1 Unit

ATC TECHNOLOGIES, INC.

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00817428021391
• NIH Device Record Key: 3a2a05e5-cbff-4671-ba7b-6a4fbb564af0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mystro
• Version Model Number: MY3015
• Catalog Number: MY3015
• Company DUNS: 023131605
• Company Name: ATC TECHNOLOGIES, 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: false
• 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	00817428021391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983623

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00817428021391]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [Mystro]

• 10817428021398: MY3015, Aspiration Needle, 5mm x 42cm, 15 Gauge Needle, 10 pack case
• 00817428021391: MY3015, Aspiration Needle, 5mm x 42cm, 15 Gauge Needle, 1 Unit