Infiniti Plus Needle Guide 610-2341

GUDID 10841436120040

Sterile needle guide (12-18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

Primary Device ID	10841436120040
NIH Device Record Key	da7dcee9-7f38-408f-9f28-df1cf63eed32
Commercial Distribution Status	In Commercial Distribution
Brand Name	Infiniti Plus Needle Guide
Version Model Number	610-2341
Catalog Number	610-2341
Company DUNS	134614411
Company Name	CIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter
Length	14 Centimeter
Width	147 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120043 [Package] Package: [24 Units] In Commercial Distribution
GS1	10841436120040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093713

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

[10841436120040]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-01-29
Device Publish Date	2021-01-21

On-Brand Devices [Infiniti Plus Needle Guide]

10841436120040	Sterile needle guide (12-18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe
00841436120036	Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe
00841436120142	Sterile needle guide (12-18ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with En
00841436120135	Sterile needle guide (18-25ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with En