FDA.reportPublic FDA data

AxoTrack I Sterile Procedure Kit

Primary DI
00841517100155
Brand
AxoTrack I Sterile Procedure Kit
Company
FUJIFILM SONOSITE, INC.
Model
P22506-02
Catalog number
P22506
Device description
Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113680000SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KITSoma Access Systems, LLC2011-12-29IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841517100156PackageGS110In Commercial Distribution
00841517100155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084151710015630841517100156
00841517100155008415171001558415171001550841517100155

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound/electromagnetic-guided needle kitA collection of sterile devices intended to be used during a needle entry procedure (e.g., central venous access, aspiration of pneumothorax) that combines ultrasonic and electromagnetic methods for needle guidance (e.g., needle depth data using Hall effect sensors virtually overlaid on ultrasound imaging). It typically includes the needle/cannula with a magnetic attachment, coupling gel, and casing intended to provide a sterile shield for a separate, compatible ultrasound/electromagnetic transducer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge18Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Shelf Life = 36 months
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xyz@xyz.com

Regulatory Flags#

DUNS number
014438860
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841517112622Sonosite STP31200-60P312002026-05-01
00841517112585L19-5P23972-25AP239722026-04-17
00841517112493C5-1P23119-30P231192026-03-30
00841517112561Sonosite PXP25000-60P250002026-03-12
00841517112530H-Universal StandP23119-25AP231192026-01-09
00841517112486rP19x/5-1 MHzP22557-11AP225572025-12-23
00841517112455L19-5P23972-25P239722025-12-18
00841517112479C5-1P23119-25P231192025-12-17
00841517111892Sonosite MTP33004-04P330042025-11-24
00841517112134Sonosite MTP33002-10P330022025-11-24
00841517112141Sonosite MTP33006-10P330062025-11-24
00841517112158Sonosite MTP33001-10P330012025-11-24
00841517112165Sonosite MTP33000-10P330002025-11-24
00841517112172Sonosite MTP33009-10P330092025-11-24
00841517112196Sonosite MTP33003-10P330032025-11-24
00841517112424Sonosite PXP25000-61P250002025-11-24
00841517112431Sonosite LXP28354-61P283542025-11-24
00841517112448Sonosite STP31200-61P312002025-11-24
00841517112288BatteryP31275-03P312752025-10-27
00841517112295BatteryP31058-03P310582025-10-27

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Primary DI, Brand, Company table
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00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
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08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
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08056304455833MyLabC30ESAOTE SPAITX2025-12-10
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08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
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08056304455451MyLabA70ESAOTE SPAITX2025-07-07
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08056304455635MyLabE80ESAOTE SPAITX2025-07-07
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08033737713037THD Procto Software SystemTHD SPAITX2021-07-19