FDA.reportPublic FDA data

PKS DRF 4-ID9.5x8

Primary DI
17290019120060
Brand
PKS DRF 4-ID9.5x8
Company
PATHKEEPER SURGICAL LTD
Model
MAS0006-01
Published
2023-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222355000PathKeeper SystemPathkeeper Surgical , Ltd.2023-03-08OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290019120060PackageGS11In Commercial Distribution
07290019120063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001912006017290019120060
07290019120063072900191200637290019120063

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/localizers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532374343
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019120018PKS Accessories Setup DRFMAS0001-012023-04-23
07290019120025PKS Patient Reference DRFMAS0002-012023-04-23
07290019120032PKS DRF 2-ID5.9MAS0003-012023-04-23
07290019120056PKS DRF 4-ID7.9MAS0005-012023-04-23
07290019120063PKS DRF 4-ID9.5x8MAS0006-012023-04-23
07290019120070PKS DRF 3-ID12.2MAS0007-012023-04-23
07290019120087PKS DRF 3-ID15MAS0008-012023-04-23
07290019120094PathKeeper SystemTPL0001-012023-04-23
07290019120179PKS Accessories Setup DRFMAS00012023-11-20
07290019120193PKS Patient Reference DRFMAS00022023-11-20
07290019120216PKS DRF 2-ID5.9MAS00032023-11-20
07290019120230PKS DRF 2-ID6.9MAS00042023-11-20
07290019120254PKS DRF 4-ID7.9MAS00052023-11-20
07290019120278PKS DRF 4-ID9.5x8MAS00062023-11-20
07290019120292PKS DRF 3-ID12.2MAS00072023-11-20
07290019120315PKS DRF 3-ID15MAS00082023-11-20
07290019120339PathKeeper Surgical Accessories KitKIT00022024-03-12
07290019120346PKS Patient Reference DRFMAS00022024-03-12
07290019120353PKS DRF 2 - ID 5.9MAS00032024-03-12
07290019120360PKS DRF 4 - ID 7.9MAS00052024-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09