FDA.reportPublic FDA data

Medicon

Primary DI
04046826010706
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
09.15.18
Catalog number
09.15.18
Device description
grooved director 18.0cm
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXBPROBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826010706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826010706040468260107064046826010706

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags#

DUNS number
315492330
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046826346812Medicon68.86.89A68.86.89A2026-06-25
04046826416676Medicon68.87.28A68.87.28A2026-06-25
04046826542337Medicon68.86.4868.86.482026-06-25
04046826543655Medicon68.86.4968.86.492026-06-25
04046826552473Medicon68.93.4168.93.412026-06-25
04046826486631Stern-a-Fix Sternal Closure System54.81.0854.81.082026-06-24
04046826442842Medicon Tray906.91.16906.91.162026-06-22
04046826485429MediExpand Cervical Expandable VBR System405.06.38405.06.382026-06-22
04046826485436MediExpand Cervical Expandable VBR System405.06.58405.06.582026-06-22
04046826486020Medicon Tray906.91.36906.91.362026-06-22
04046826002572Medicon03.05.1703.05.172026-04-30
04046826020507Medicon14.06.1214.06.122026-04-30
04046826023331Medicon15.70.1415.70.142026-04-30
04046826023362Medicon15.71.1415.71.142026-04-30
04046826050849Medicon47.30.1347.30.132026-04-30
04046826063764Medicon51.99.5051.99.502017-05-31
04046826032807Medicon24.26.1224.26.122026-04-13
04046826531508Medicon68.94.70A68.94.70A2026-04-02
04046826531522Medicon68.94.72A68.94.72A2026-04-02
04046826531539Medicon68.94.76A68.94.76A2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134554FORCECORD Passing ProbeXIROS LTDHXB2026-07-06
06974940307830endophixSuzhou Endophix Co., Ltd.HXB2026-06-23
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800322758151Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXB2026-04-21
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
08809885720001Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXB2025-03-17
08809885720018Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXB2025-03-17
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19
10649111297496SklarSKLAR CORPORATIONHXB2019-03-19
10649111376351Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111376474Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377655Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377785Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111255212Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255342Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255502Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255649Sklar®SKLAR CORPORATIONHXB2019-02-14