Arthocare

GUDID 08100410603067

Provision

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: 08100410603067
• NIH Device Record Key: 860a77f4-b6a3-4768-926b-c7acc4e5f031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthocare
• Version Model Number: A1325-01
• Company DUNS: 016889401
• Company Name: Provision
• 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	08100410603067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173741

FDA Product Code

• NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-09
• Device Publish Date: 2019-12-12

On-Brand Devices [Arthocare ]

• 08100410603289: AC4330-01
• 08100410603067: A1325-01
• 00810041063274: AC4330-01
• 00810041063052: A1325-01