Infiniti Plus Needle Guide 610-2340

GUDID 00841436120036

Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use
Primary Device ID00841436120036
NIH Device Record Key03d4a7b9-c2b1-4446-8a44-324d0c70cf8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfiniti Plus Needle Guide
Version Model Number610-2340
Catalog Number610-2340
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 Latexfalse
Labeled No Natural Rubber Latextrue
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
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

Device Dimensions

Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter
Length14 Centimeter
Width147 Centimeter

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
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
GS100841436120036 [Package]
Contains: 10841436120033
Package: [24 Units]
In Commercial Distribution
GS110841436120033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

[00841436120036]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-29
Device Publish Date2021-01-21

On-Brand Devices [Infiniti Plus Needle Guide]

10841436120040Sterile needle guide (12-18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe
00841436120036Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe
00841436120142Sterile needle guide (12-18ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with En
00841436120135Sterile needle guide (18-25ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with En
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.