FDA.report

N/A

Primary DI
00613994575463
Brand
N/A
Company
MEDTRONIC NAVIGATION, INC.
Model
9734119
Device description
RETRACTOR HOLDER 9734119 HEADHOLDER V2
Published
2016-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994575463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994575463006139945754636139945754630613994575463

GMDN Terms

TermDefinition
Extremity MRI system, permanent magnetA diagnostic magnetic resonance imaging (MRI) system employing permanent magnet technology specifically designed to image only the head and neck or limbs. Extremity imaging systems are typically closed bore designs with cylindrical or rectangular bore openings but can be "open" bore designs. They include MRI systems with conventional extremity imaging capabilities, conventional systems capable of performing spectroscopy or other real-time imaging procedures necessary for interventional and therapeutic MRI applications, and dedicated MR spectroscopy systems.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
835233107
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00763000738570Aquamantys™23-301-12026-02-27
00763000738334AxiEM™97353182026-02-15
00763000738341AxiEM™97353172026-02-15
00763000738358AxiEM™97350192026-02-15
00763000738365AxiEM™97350182026-02-15
00763000738372AxiEM™97350172026-02-15
00763000738389AxiEM™97350162026-02-15
00763000738396AxiEM™97350152026-02-15
00763000738402AxiEM™97353002026-02-15
00763000738433AxiEM™97353192026-02-15
00763000521486Visualase V2 MRI-Guided Laser Ablation System97364222026-02-02
00763000738488AxiEM™97354282026-01-01
00613994462428O-Arm9733292R2025-11-27
00763000255565N/A97346632025-09-19
00763000255589N/A97346642025-09-19
00199150014699NavLock™97344922025-09-18
00199150014729SOLERA97352842025-09-18
00199150014736SOLERA97352852025-09-18
00763000244965N/A97342742025-09-18
00763000244972N/A97342752025-09-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00873263009468microTargeting™ PlatformFHC, INC.HAW2026-03-16
00873263009475microTargeting™ Measurement ProbeFHC, INC.HAW2026-03-16
08800050904769Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
08800050904776Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
00763000738334AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738341AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738402AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738433AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
04056481147808Drill Depth Stop Cranial 4.9 mmBrainlab SEHAW2026-02-11
00873263009451microTargeting™ Drill GuideFHC, INC.HAW2026-02-10
00860009258105COMPASS CYGNUS-PFS IGS SystemCompass InternationalHAW2026-01-29
00860009258112COMPASS Stereotactic SystemCompass InternationalHAW2026-01-29
07630345728975Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
07630699701792Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
00873263009574STar™ Drive Frame AdapterFHC, INC.HAW2026-01-25
07630030846656Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
07630030846663Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
00763000738488AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-01-01
00860012211906SOLOPASS 2.0 Patient Interface DeviceinTRAvent Medical Partners, L.P.HAW2025-12-11
00763000337292N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337308N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337315N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337322N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000340261N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405144N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405151N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000927264MedtronicMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000943219N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
07340201502273Leksell Stereotactic SystemElekta Solutions ABHAW2025-09-17