FDA.report

Medicon

Primary DI
04046826000998
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
01.67.01
Catalog number
01.67.01
Device description
Simon fistula knife 20cm
Published
2020-09-24
Public version status
New
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
EMFKNIFE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826000998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826000998040468260009984046826000998

GMDN Terms

TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
DM exempt
true
Premarket exempt
true
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 DIBrandModelCatalogPublished
04046826447953Medicon Tray906.91.25906.91.252026-03-24
04046826495923Medicon Tray906.91.86906.91.862026-03-24
04046826495978Medicon Tray906.91.33906.91.332026-03-24
04046826445928Medicon Tray906.91.22906.91.222026-03-20
04046826445935Medicon Tray906.91.23906.91.232026-03-20
04046826447342Medicon Tray906.91.24906.91.242026-03-20
04046826055493Medicon Tray49.97.8249.97.822026-03-19
04046826435400MediExpand Cervical Expandable VBR System 905.80.01905.80.012026-03-19
04046826472061Medicon58.82.2658.82.262026-03-19
04046826472078Medicon58.82.2758.82.272026-03-19
04046826472085Medicon58.82.2858.82.282026-03-19
04046826492632Medicon70.46.2570.46.252026-03-19
04046826492649Medicon70.46.2070.46.202026-03-19
04046826112790Medicon66.54.5066.54.502026-03-04
04046826118327Medicon68.03.5268.03.522026-02-27
04046826118341Medicon68.03.5468.03.542026-02-27
04046826532871Medicon68.83.47A68.83.47A2026-01-19
04046826533427Medicon68.83.44A68.83.44A2026-01-19
04046826055158Medicon Tray49.97.1249.97.122025-12-17
04046826068424Medicon52.70.7152.70.712025-12-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08681506800343SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-26
08681506800350SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-24
00848530100162Disposable Wire-Guided Scapel for Central Venous CannulationSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
00848530100179GuideBlade Sample KitSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
08681506801302SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-09
08681506801227SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-08
04046826114374Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftEMF2025-12-01
00190776404604MillenniumAvalign Technologies, Inc.EMF2025-07-10
00190776403058MillenniumAvalign Technologies, Inc.EMF2025-07-01
00190776403201MillenniumAvalign Technologies, Inc.EMF2025-07-01
08717903490280Humeca Silver knifeHumeca B.V.EMF2025-05-20
08717903490297Humeca Humby knifeHumeca B.V.EMF2025-05-20
08717903490303Humeca Cobbett knifeHumeca B.V.EMF2025-05-20
08717903490310Humeca Watson knifeHumeca B.V.EMF2025-05-20
08717903490327Humeca Humby long knifeHumeca B.V.EMF2025-05-20
00190776397616MillenniumAvalign Technologies, Inc.EMF2025-05-16
00190776393137MillenniumAvalign Technologies, Inc.EMF2025-05-05
04049047000143GimmiGimmi GmbHEMF2025-04-16
04049047000297GimmiGimmi GmbHEMF2025-04-16
04049047000303GimmiGimmi GmbHEMF2025-04-16
04049047000358GimmiGimmi GmbHEMF2025-04-16
04049047000365GimmiGimmi GmbHEMF2025-04-16
04049047000402GimmiGimmi GmbHEMF2025-04-16
04049047000426GimmiGimmi GmbHEMF2025-04-16
04049047000457GimmiGimmi GmbHEMF2025-04-16
04049047000549GimmiGimmi GmbHEMF2025-04-16
04049047000853GimmiGimmi GmbHEMF2025-04-16
04049047000860GimmiGimmi GmbHEMF2025-04-16
04049047000877GimmiGimmi GmbHEMF2025-04-16
04049047000884GimmiGimmi GmbHEMF2025-04-16