FDA.reportPublic FDA data

Philips Healthcare

Primary DI
57613327664084
Brand
Philips Healthcare
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
014R
Catalog number
014R
Published
2025-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWBInterventional fluoroscopic x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200195000NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.2020-06-22OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327664084PackageGS110In Commercial Distribution
07613327664089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332766408457613327664084
07613327664089076133276640897613327664089

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, reprocessedA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00857088008684TrackXTrackX Technology, LLCOWB2026-05-11
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
00841962120548Alpine Stirrups, Metric, LeftQfixOWB2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixOWB2026-04-14
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00850073646120TrackXTrackX Technology, LLCOWB2026-04-08
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-03-25
00850079606050EmitterOXOS Medical, Inc.OWB2026-03-25
00850073646106TrackXTrackX Technology, LLCOWB2026-02-24
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
00841962120388Lumen AirShuttleQfixOWB2025-12-02
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
00850073646045TrackXTrackX Technology, LLCOWB2025-10-24
00850073646052TrackXTrackX Technology, LLCOWB2025-10-24
00850073646069TrackXTrackX Technology, LLCOWB2025-10-24
00850073646076TrackXTrackX Technology, LLCOWB2025-10-24
00850073646083TrackXTrackX Technology, LLCOWB2025-10-24
00850073646113TrackXTrackX Technology, LLCOWB2025-10-15
00841962119467Alpine StirrupsQfixOWB2025-07-09
00841962119474Alpine StirrupsQfixOWB2025-07-09
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
08809244060465GenorayGENORAY CO., LTD.OWB2025-05-02