Pretzelflex - Surgical Retraction System

GUDID 05051986008561

5mm Pretzelflex Retractor

SURGICAL INNOVATIONS LIMITED

Externally-anchored laparoscopic retractor

• Primary Device ID: 05051986008561
• NIH Device Record Key: 3c29bddb-e3cd-4264-9610-f99ccdddb2e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pretzelflex - Surgical Retraction System
• Version Model Number: SHR7001
• Company DUNS: 771051935
• Company Name: SURGICAL INNOVATIONS LIMITED
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	05051986008561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123110

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[05051986008561]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-23

On-Brand Devices [Pretzelflex - Surgical Retraction System]

• 05051986009667: 3mm Pretzelflex Retractor
• 05051986008561: 5mm Pretzelflex Retractor
• 05051986009759: 3mm Sterilisation Sleeve
• 05051986009742: 5mm Sterilisation Sleeve