Pretzelflex - Surgical Retraction System

GUDID 05051986009742

5mm Sterilisation Sleeve

SURGICAL INNOVATIONS LIMITED

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container
Primary Device ID05051986009742
NIH Device Record Key3d2140cf-a7de-4c1c-bc41-cd2d08768ee6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePretzelflex - Surgical Retraction System
Version Model NumberSHR7101
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
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]
GS105051986009742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery
GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

Moist Heat or Steam Sterilization


[05051986009742]

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 [Pretzelflex - Surgical Retraction System]

050519860096673mm Pretzelflex Retractor
050519860085615mm Pretzelflex Retractor
050519860097593mm Sterilisation Sleeve
050519860097425mm Sterilisation Sleeve

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