ANKYRAS

Primary DI
08437025622016
Brand
ANKYRAS
Company
MENTICE SPAIN S.L.
Model
v4.0.4-US
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZOSoftware For Visualization Of Vascular Anatomy And Intravascular DevicesRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250160000ANKYRASMentice Spain S.L.2025-05-06PZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437025622016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437025622016084370256220168437025622016

GMDN Terms#

Term, Definition table
TermDefinition
Surgical simulation systemA mobile computerized assembly of mains electricity (AC-powered) devices intended to collect and manipulate medical imaging [e.g., computed tomography (CT), magnetic resonance imaging (MRI)] data to create a patient-specific, virtual, three-dimensional (3-D), interactive model to enable a surgeon to simulate, rehearse, and plan a surgical procedure (e.g., cranial) prior to surgery. It includes dedicated software, and dedicated and/or off-the-shelf hardware such as a cart, a personal computer (PC), monitors, 3-D glasses, and a controller to simulate surgical devices and perform measurements. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
471570274
Device count
1
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665786000018Sim&SizeSIM&CUREPZO2026-03-13
03665786000070Sim&SizeSIM&CUREPZO2025-02-11
03665786000032Sim&SizeSIM&CUREPZO2023-03-14
03665786000063Sim&SizeSIM&CUREPZO2022-06-24
03665786000049Sim&SizeSIM&CUREPZO2021-06-06
03665786000056Sim&SizeSIM&CUREPZO2021-06-06
03665786000025Sim&SizeSIM&CUREPZO2020-07-30
B642SURGICALPREVIEW3300SurgicalPreviewENDOVANTAGE LLCPZO2019-11-27
B642SURGICALPREVIEW3200SurgicalPreviewENDOVANTAGE LLCPZO2019-11-05
B642SURGICALPREVIEW3100SurgicalPreviewENDOVANTAGE LLCPZO2019-10-23
B642SURGICALPREVIEW3000SurgicalPreviewENDOVANTAGE LLCPZO2019-09-12
B642SURGICALPREVIEW2600SurgicalPreviewENDOVANTAGE LLCPZO2019-06-07
B642SURGICALPREVIEW2500SurgicalPreviewENDOVANTAGE LLCPZO2019-04-30
B642SURGICALPREVIEW2400SurgicalPreviewENDOVANTAGE LLCPZO2019-02-07
B642SURGICALPREVIEW2300SurgicalPreviewENDOVANTAGE LLCPZO2019-01-28
B642SURGICALPREVIEW2200SurgicalPreviewENDOVANTAGE LLCPZO2018-12-07
B642SURGICALPREVIEW2100SurgicalPreviewENDOVANTAGE LLCPZO2018-11-30
B642SURGICALPREVIEW1200SurgicalPreviewENDOVANTAGE LLCPZO2018-04-29
B642SURGICALPREVIEW1100SurgicalPreviewENDOVANTAGE LLCPZO2018-04-16
B642SURGICALPREVIEW100SurgicalPreviewENDOVANTAGE LLCPZO2018-04-06