Needle Guide Starter Kit 674-059

GUDID 00841436107181

Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti Plus™ (18,20,21/22,25GA) needle guides (3), (14 x 147cm) CIV-Flex™ covers (5), gel and bands

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

Primary Device ID	00841436107181
NIH Device Record Key	3ab38203-a9ab-4b98-9f58-a8769ae3de87
Commercial Distribution Status	In Commercial Distribution
Brand Name	Needle Guide Starter Kit
Version Model Number	674-059
Catalog Number	674-059
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	false
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	false
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
Phone	+1(319)248-6502
Email	regulatory@civco.com
Phone	+1(319)248-6502
Email	regulatory@civco.com

Device Dimensions

Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch
Length	2.8 Inch
Height	1.3 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Away from Sunlight
Storage Environment Temperature	Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436107181 [Primary]
GS1	20841436117757 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093713

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2019-10-07
Device Publish Date	2017-08-22

On-Brand Devices [Needle Guide Starter Kit]

00841436113731	Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
00841436110921	Reusable non-sterile single-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 147c
00841436110150	Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CI
00841436110143	Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CI
00841436110136	Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) CI
00841436110129	Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 14
00841436110112	Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 14
00841436110105	Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5),
00841436110099	Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
00841436110082	Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) C
00841436110044	Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guide (5), (14 x 147cm) CI
00841436109963	Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) C
00841436109956	Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 147cm) C
00841436109925	Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
00841436109901	Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
00841436107198	Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P
00841436107181	Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P
00841436107051	Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P
00841436107037	Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 14
00841436107020	Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147
00841436107013	Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) with
00841436107006	Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P
00841436106993	Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P
00841436106986	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436106979	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436106962	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436106955	Reusable non-sterile bracket with Infiniti Plus™ (12,14,16,18GA) needle guides (2), Infiniti P
00841436181198	Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5),
00841436107143	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120838	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides(2), Infiniti
00841436120821	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120814	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120807	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides(2), Infiniti
00841436120791	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120784	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120777	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120760	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120418	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120395	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436120371	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436118620	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436110860	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
00841436114288	Reusable non-sterile single-angle bracket with AccuSITE™ needle guides (5) and (14 × 147cm) C
00841436121637	Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
20841436122713	Reusable non-sterile single-angle bracket with AccuSITE™ needle guides (5) and (14 × 147cm) C