GE Reusable Endocavity Needle Guide 5776036

GUDID 00841436113700

Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare IC9 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, reusable
Primary Device ID00841436113700
NIH Device Record Keyf4557da9-bc54-4c51-ad7e-b9ab27c2e8f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGE Reusable Endocavity Needle Guide
Version Model Number5776036
Catalog Number5776036
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch
Width1.1 Inch
Length7.1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436113700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-13
Device Publish Date2021-09-03

On-Brand Devices [GE Reusable Endocavity Needle Guide]

20841436114084Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
20841436114077Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
00841436110570Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
00841436111973Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar
00841436113700Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcar

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