FastClamp - FastClamp System

GUDID 05051986011578

FastClamp Bar 500mm

SURGICAL INNOVATIONS LIMITED

Medical table clamp
Primary Device ID05051986011578
NIH Device Record Keyfb44d720-8d06-4ed4-9da6-94200268eb16
Commercial Distribution StatusIn Commercial Distribution
Brand NameFastClamp - FastClamp System
Version Model NumberBC-1050-01
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
GS105051986011578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05051986011578]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-31
Device Publish Date2016-09-23

On-Brand Devices [FastClamp - FastClamp System]

05051986011622Extended Clamp Arm assy
05051986011608FastClamp Bariatric Bar
05051986011592FastClamp Bar 700mm
05051986011578FastClamp Bar 500mm
05051986011547FastClamp Bar 300mm
05051986011530Bariatric Fastclamp
05051986006628Instrument Clamp Assembly
05051986006574Table Clamp
05051986001210FastClamp

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