Medtronic

GUDID 06948318946785

ProdiGI Single Use Electrosurgical Knife/ProdiGI Multi-Functional Electrosurgical Knife

Anrei Medical(HZ) Co.,Ltd.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 06948318946785
• NIH Device Record Key: c83ef624-2995-4ec9-ab31-e392a7757ff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic
• Version Model Number: EKM-425D
• Company DUNS: 529128653
• Company Name: Anrei Medical(HZ) Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06948318946785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212999

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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: 2022-04-14
• Device Publish Date: 2022-04-06

On-Brand Devices [Medtronic]

• 06948318946785: ProdiGI Single Use Electrosurgical Knife/ProdiGI Multi-Functional Electrosurgical Knife
• 06948318946778: ProdiGI Single Use Electrosurgical Knife/ProdiGI Multi-Functional Electrosurgical Knife