NeedleGuide H44901AX, H44901AX-5

GUDID 00841436121996

Sterile endocavity needle guide with (3.5x20cm) latex cover (1) for use with GE Healthcare RIC10 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Needle guide, single-use
Primary Device ID00841436121996
NIH Device Record Keye9a5499d-ffdd-4f50-8fc7-02679d6418e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedleGuide
Version Model NumberH44901AX
Catalog NumberH44901AX, H44901AX-5
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
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
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436121996 [Package]
Contains: 10841436121993
Package: [24 Units]
In Commercial Distribution
GS100841436122009 [Package]
Contains: 10841436121993
Package: [5 Units]
In Commercial Distribution
GS110841436121993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


[00841436121996]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [NeedleGuide]

00841436121996Sterile endocavity needle guide with (3.5x20cm) latex cover (1) for use with GE Healthcare RIC10
00841436121989Sterile endocavity needle guide for use with GE Healthcare RIC10 transducers

Trademark Results [NeedleGuide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEEDLEGUIDE
NEEDLEGUIDE
88060942 not registered Dead/Abandoned
Medaphor Limited
2018-08-01

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