Tracking Bracket Starter Kit 10441188

GUDID 00841436100304

Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4V1 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable

Primary Device ID	00841436100304
NIH Device Record Key	6a88845b-9c2b-4127-80b5-dff97c6e7ba4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tracking Bracket Starter Kit
Version Model Number	10441188
Catalog Number	10441188
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

Device Dimensions

Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch
Height	1.37 Inch
Length	2.15 Inch

Operating and Storage Conditions

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
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	00841436100304 [Primary]
GS1	20841436117382 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092619

FDA Product Code

IYO	System, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-12-23
Device Publish Date	2017-08-22

On-Brand Devices [Tracking Bracket Starter Kit]

00841436110945	Reusable non-sterile tracking bracket with (5 tapered to 1.9 × 32cm) NeoGuard ™ covers (5) an
00841436106825	Reusable non-sterile multi-angle PercuNav™ tracking bracket with Ultra-Pro II™ Needle guides
00841436106818	Reusable non-sterile multi-angle PercuNav™ tracking bracket with Ultra-Pro II™ Needle guides
00841436106764	Reusable non-sterile PercuNav™ tracking bracket with Infiniti Plus™ (12, 14, 16, 18GA) needl
00841436106757	Reusable non-sterile multi-angle PercuNav™ tracking bracket with Ultra-Pro II™ Needle guides
00841436106740	Reusable non-sterile multi-angle PercuNav™ tracking bracket with Ultra-Pro II™ Needle guides
00841436106191	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Sam
00841436106184	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Sam
00841436105699	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esa
00841436105682	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Es
00841436105675	Reusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5)
00841436105668	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Es
00841436105651	Reusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5)
00841436105583	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esa
00841436100328	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushe
00841436100304	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushe
00841436100298	Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x
00841436100281	Reusable non-sterile tracking bracket with (17.8 x 147cm) CIV-Flex™ covers (5), cleaning brush
00841436100274	Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (17.8
00841436111171	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Sam
00841436120166	Reusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5),
00841436119986	Reusable non-sterile tracking bracket with (14x91.5cm) CIV-Flex™ covers (5), for use with Sams
00841436119948	Reusable non-sterile tracking bracket with (14x91.5cm) CIV-Flex™ covers (5), for use with Sams
00841436118811	Reusable non-sterile tracking bracket with (11.9 tapered to 3.8x61cm) CIV-Flex™ covers (5) for
20841436115920	Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x
20841436118396	Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with Sam