Summit Imagine Processing Unit

GUDID 00860003634615

Pristine Surgical LLC

Rigid optical arthroscope, single-use

• Primary Device ID: 00860003634615
• NIH Device Record Key: bb574a61-ae68-44dd-8354-84777733c885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit Imagine Processing Unit
• Version Model Number: PS-IPU001
• Company DUNS: 080976458
• Company Name: Pristine Surgical LLC
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003634615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223244

FDA Product Code

• HRX: Arthroscope

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: 2024-05-28
• Device Publish Date: 2024-05-20

Devices Manufactured by Pristine Surgical LLC

• 00860003634615 - Summit Imagine Processing Unit: 2024-05-28
• 00860003634615 - Summit Imagine Processing Unit: 2024-05-28
• 10860003634605 - Summit Single Use Surgical Arthroscope: 2024-05-28