FDA.reportPublic FDA data

N/A

Primary DI
00885074338255
Brand
N/A
Company
MEDTRONIC NAVIGATION, INC.
Model
9732221
Device description
DG KIT 9732221 SHORT DRILL GUIDE
Published
2016-09-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074338255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074338255008850743382558850743382550885074338255

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000404871StealthStation™97359632026-05-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012056804Zeta Stylet — SZeta Surgical Inc.HAW2026-05-26
00763000404871StealthStation™MEDTRONIC NAVIGATION, INC.HAW2026-05-23
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