YelloPort Elite - Laparoscopic Port Access System

GUDID 05051986012407

10x75 Dilating Pyramidal Trocar

SURGICAL INNOVATIONS LIMITED

Laparoscopic trocar blade, reusable

• Primary Device ID: 05051986012407
• NIH Device Record Key: 5c563a05-b2d8-4622-93b9-da5a7e65d867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YelloPort Elite - Laparoscopic Port Access System
• Version Model Number: ET1007507
• 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	05051986012407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190592

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

[05051986012407]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-16
• Device Publish Date: 2020-10-08

On-Brand Devices [YelloPort Elite - Laparoscopic Port Access System]

• 05051986012124: 10mm Hasson Adaptor Seals 5pk
• 05051986012766: 12x75 Locking Shielded Trocar
• 05051986012735: 10x75 Locking Shielded Trocar
• 05051986012681: 12x150 Locking Shielded Trocar
• 05051986012674: 12x105 Locking Shielded Trocar
• 05051986012629: 10x150 Locking Shielded Trocar
• 05051986012612: 10x105 Locking Shielded Trocar
• 05051986012452: 12x75 Dilating Pyramidal Trocar
• 05051986012445: 12x75 Blunt Trocar
• 05051986012438: 12x75 Pencil Point Trocar
• 05051986012407: 10x75 Dilating Pyramidal Trocar
• 05051986012391: 10x75 Blunt Trocar
• 05051986012384: 10x75 Pencil Point Trocar
• 05051986012377: 12x75 Cannula
• 05051986012360: 10x75 Cannula
• 05051986012131: 12mm Hasson Adaptor Seals 5pk
• 05051986012117: Hasson Adaptor 12mm
• 05051986012100: Hasson Adaptor 10mm
• 05051986002217: 12x150 Dilating Pyramidal Trocar
• 05051986002200: 12x150 Blunt Trocar
• 05051986002194: 12x150 Pencil Point Trocar
• 05051986002187: 12x105 Dilating Pyramidal Trocar
• 05051986002170: 12x105 Blunt Trocar
• 05051986002149: 12x105 Pencil Point Trocar
• 05051986002132: 10x150 Dilating Pyramidal Trocar
• 05051986002125: 10x150 Blunt Trocar
• 05051986002118: 10x150 Pencil Point Trocar
• 05051986002101: 10x105 Dilating Pyramidal Trocar
• 05051986002095: 10x105 Blunt Trocar
• 05051986002040: 12x150 Cannula
• 05051986002033: 12x105 Cannula
• 05051986002026: 10x150 Cannula
• 05051986001579: 10x105 Cannula
• 05051986002224: 5-12 Single Use Universal Seal
• 05051986013596: 12 x 150 Cannula XL
• 05051986013589: 12 x 105 Cannula XL
• 05051986013572: 12 x 75 Cannula XL