Tracking Bracket 653-002

GUDID 00841436106054

Sterile tracking bracket for use with Hologic ATEC biopsy instrument

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking holder, single-use Ultrasound imaging system tracking positioner, single-use Ultrasound imaging system tracking positioner, single-use Ultrasound imaging system tracking positioner, single-use Ultrasound imaging system tracking positioner, single-use Ultrasound imaging system tracking positioner, single-use Ultrasound imaging system tracking positioner, single-use
Primary Device ID00841436106054
NIH Device Record Keycaee5bab-23cc-4adb-94fb-b345133f99d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracking Bracket
Version Model Number653-002
Catalog Number653-002
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 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

Device Dimensions

Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter
Length5.7 Centimeter
Width4.6 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436106054 [Package]
Contains: 10841436106051
Package: [12 Units]
In Commercial Distribution
GS110841436106051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

[00841436106054]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2017-08-22

On-Brand Devices [Tracking Bracket]

00841436106887Sterile PercuNav™ tracking bracket with (2.6 x 20cm) latex cover for use with Philips C10-4ec
00841436106870Sterile PercuNav™ tracking bracket for use with Philips C10-4ec transducers
00841436106054Sterile tracking bracket for use with Hologic ATEC biopsy instrument
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00841436106214Reusable non-sterile tracking bracket for use with Samsung Medison CA1-6A and CA1-7A transducers
00841436120173Reusable non-sterile tracking bracket for use with Samsung Medison EA2-11AR/EA2-11AV transducers
00841436119993Reusable non-sterile tracking bracket for use with Samsung Medison CA1-7S transducers
00841436119955Reusable non-sterile tracking bracket for use with Samsung Medison LA4-18A transducers
00841436118828Reusable non-sterile tracking bracket for use with Samsung Medison EA2-11AR/EA2-11AV transducers
20841436118327Reusable non-sterile tracking bracket for use with Samsung Medison E3-12A transducers
20841436118402Reusable non-sterile tracking bracket for use with Samsung Medison CA3-10A transducers
00841436106047Sterile tracking bracket for use with Hologic Celero biopsy instrument
00841436120234Reusable non-sterile Verza™ tracking bracket for use with Siemens Healthineers 15L4-2 transduc
20841436120467Reusable non-sterile tracking bracket for use with Samsung Medison LM2-18 transducers
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