FDA.reportPublic FDA data

Flexarm Universal

Primary DI
04260759931314
Brand
Flexarm Universal
Company
Fiagon GmbH
Model
E011973
Device description
The Flexarm Universal is a support device for a navigation sensor that creates an electromagnetic field. It is mounted on the procedure chairs or table and consists of an articulating arm for positioning the navigation sensor in a desired fixed position.
Published
2026-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, And Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260759931314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260759931314042607599313144260759931314

Contacts#

Phone, Email table
PhoneEmail
13364282241support@fiagon.com

Regulatory Flags#

DUNS number
312623008
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
true
Expiration date on label
false
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
04260759931697VirtuEye ProE011440E0114402026-08-17
EFIAE0135061VenSure Balloon Sinus Dilation System1E 01 35062021-06-11
EFIAE0135161VenSure Nav Balloon Sinus Dilation System12021-06-11
04260759931246VenSure Balloon Dilation System1E 01 35262022-11-10
04260759931680VenSure 4D Balloon Dilation System1E 01 35662025-09-18
04260759931260VenSure Nav Balloon Dilation System1E 01 35462022-11-10
04260759931253VenSure Light Balloon Dilation System1E 01 35362022-10-14
EFIAE0135921Vensure Inflation Device1E 01 35922022-01-21
04260759930003Integrated HeadrestE0119702025-06-25
04260759930133Navigation Unit Cube4DE011106-HD/8E011106-HD/82025-01-16
042607599301574K Navigation Unit Cube4DE011106-4K/8E011106-4K/82025-01-16
04260759930249Navigation SensorA011000A0110002025-01-16
04260759930300FlexPointerE012002E0120022025-01-16
04260759930317FlexPointer 1.5 mmE012004E0120042025-01-16
04260759930324FlexTube 3mmE012104E0121042025-01-16
04260759930331FlexTube 4mmE012106E0121062025-01-16
04260759930348PointerTube KeatE012107E0121072025-01-16
04260759930355PointerTube KennedyE012108E0121082025-01-16
04260759930447Localizer Adhesive Pad C-TypeE012202CE012202C2025-01-16
EFIAE012202C1Localizer Adhesive padC-Type2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780544197TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544210TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544234TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544258TruDi®ACCLARENT, INC.PGW2026-11-03
10381780544272TruDi®ACCLARENT, INC.PGW2026-11-03
00824846012832StealthMEDTRONIC NAVIGATION, INC.PGW2026-10-30
00763000945817ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945824ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945831ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945848ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000945855ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
00763000957858ApexCut EMMEDTRONIC XOMED, INC.PGW2026-10-24
10381780544081TruDi®ACCLARENT, INC.PGW2026-10-15
04260759931697VirtuEye ProFiagon GmbHPGW2026-08-17
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2026-08-07
00199150006427Stealth AXiSMEDTRONIC NAVIGATION, INC.PGW2026-04-24
00763000738358AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738365AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738372AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
04056481146702Curve NavigationBrainlab SEPGW2025-10-13
04260759930003Integrated HeadrestFiagon GmbHPGW2025-06-25
04260759930133Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
042607599301574K Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
04260759930249Navigation SensorFiagon GmbHPGW2025-01-16
04260759930300FlexPointerFiagon GmbHPGW2025-01-16
04260759930317FlexPointer 1.5 mmFiagon GmbHPGW2025-01-16
04260759930324FlexTube 3mmFiagon GmbHPGW2025-01-16
04260759930331FlexTube 4mmFiagon GmbHPGW2025-01-16