GE Reusable Endocavity Needle Guide H46721R

GUDID 20841436114084

Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare 4DE7C, RIC5-9, and RIC6-12 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, reusable
Primary Device ID20841436114084
NIH Device Record Key3ee656e2-9435-4de3-a9d0-e39e68b0c64b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGE Reusable Endocavity Needle Guide
Version Model NumberH46721R
Catalog NumberH46721R
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

Device Dimensions

Width0.6 Inch
Length7.46 Inch
Width0.6 Inch
Length7.46 Inch
Width0.6 Inch
Length7.46 Inch
Width0.6 Inch
Length7.46 Inch
Width0.6 Inch
Length7.46 Inch
Width0.6 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436114219 [Primary]
GS100841436114318 [Primary]
GS120841436114084 [Direct Marking]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-23
Device Publish Date2018-09-05

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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