FDA.reportPublic FDA data

40003 PercuNav Coaxial Needle Tracker, 16G x 11 cm

Primary DI
00884838082991
Brand
40003 PercuNav Coaxial Needle Tracker, 16G x 11 cm
Company
Philips Ultrasound LLC
Model
989605428004
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYOSystem, imaging, pulsed echo, ultrasonic
JAKSystem, x-ray, tomography, computed
LLZSystem, image processing, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132087000PERCUNAV SYSTEMPhilips Health Care2013-07-24JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838082991PrimaryGS10
00884838083080Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838082991008848380829918848380829910884838082991
00884838083080008848380830808848380830800884838083080

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
063377717
Device count
2
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838128095Affiniti 50 Diagnostic Ultrasound System7952082026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound System7952102026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound System7952182026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound System7952342026-09-18
00884838129276Ultrasound Workspace7.0.X2025-08-29
00884838125186Ultrasound Workspace6.0.2.02025-03-24
00884838124233TOMTEC ARENATTA2.532024-07-03
00884838122277QLAB Advanced Quantification Software7950412024-05-29
00884838115323QLAB Advanced Quantification SoftwareRelease 15.67950412024-04-03
00884838121423TOMTEC ARENATTA27951302023-07-19
00884838115958Philips FetView7952682023-03-23
00884838103603QLAB Advanced Quantification Software9896067204412021-12-13
00884838098220Qlab Quantification Software9896067100712020-12-10
00884838102903Qlab Quantification Software 13.09896054964822020-12-10
00884838091672QLAB Advanced Quantification Software9896054964812019-06-27
00884838059788QLAB Quantification SoftwareRelease 10.52016-03-31
00884838070837QLAB Quantification SoftwareRelease 10.72017-02-01
00884838078079Q-StationRelease 3.72017-02-01
00884838083493QLAB Advanced Ultrasound Quantification SoftwareRelease 10.82017-04-13
00884838083509Q-Station Application SoftwareRelease 3.82017-04-13

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