YelloPort Elite - Laparoscopic Port Access System

GUDID 05051986012445

12x75 Blunt Trocar

SURGICAL INNOVATIONS LIMITED

Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable Laparoscopic trocar blade, reusable
Primary Device ID05051986012445
NIH Device Record Key66c63bc8-93ea-4a06-947c-f276741bdc95
Commercial Distribution StatusIn Commercial Distribution
Brand NameYelloPort Elite - Laparoscopic Port Access System
Version Model NumberET1207504
Company DUNS771051935
Company NameSURGICAL INNOVATIONS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105051986012445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


[05051986012445]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

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

0505198601212410mm Hasson Adaptor Seals 5pk
0505198601276612x75 Locking Shielded Trocar
0505198601273510x75 Locking Shielded Trocar
0505198601268112x150 Locking Shielded Trocar
0505198601267412x105 Locking Shielded Trocar
0505198601262910x150 Locking Shielded Trocar
0505198601261210x105 Locking Shielded Trocar
0505198601245212x75 Dilating Pyramidal Trocar
0505198601244512x75 Blunt Trocar
0505198601243812x75 Pencil Point Trocar
0505198601240710x75 Dilating Pyramidal Trocar
0505198601239110x75 Blunt Trocar
0505198601238410x75 Pencil Point Trocar
0505198601237712x75 Cannula
0505198601236010x75 Cannula
0505198601213112mm Hasson Adaptor Seals 5pk
05051986012117Hasson Adaptor 12mm
05051986012100Hasson Adaptor 10mm
0505198600221712x150 Dilating Pyramidal Trocar
0505198600220012x150 Blunt Trocar
0505198600219412x150 Pencil Point Trocar
0505198600218712x105 Dilating Pyramidal Trocar
0505198600217012x105 Blunt Trocar
0505198600214912x105 Pencil Point Trocar
0505198600213210x150 Dilating Pyramidal Trocar
0505198600212510x150 Blunt Trocar
0505198600211810x150 Pencil Point Trocar
0505198600210110x105 Dilating Pyramidal Trocar
0505198600209510x105 Blunt Trocar
0505198600204012x150 Cannula
0505198600203312x105 Cannula
0505198600202610x150 Cannula
0505198600157910x105 Cannula
050519860022245-12 Single Use Universal Seal

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