FDA.reportPublic FDA data

Medicon

Primary DI
04046826120009
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.51.01
Catalog number
68.51.01
Device description
Tessier maxillary mobilizer lf
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826120009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826120009040468261200094046826120009

GMDN Terms#

Term, Definition table
TermDefinition
ENT mobilizerA hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. This is a reusable 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
04046826047443Medicon44.90.7244.90.722026-07-31
04046826380830Medicon Tray906.90.57906.90.572026-07-30
04046826380939Medicon Tray906.90.76906.90.762026-07-30
04046826413187Medicon Tray906.92.05906.92.052026-07-30
04046826413194Medicon Tray906.92.06906.92.062026-07-30
04046826413200Medicon Tray906.92.08906.92.082026-07-30
04046826438180Medicon Tray906.92.18906.92.182026-07-30
04046826495800Medicon Tray906.91.32906.91.322026-07-30
04046826495954Medicon Tray906.91.87906.91.872026-07-30
04046826486228Medicon68.85.23A68.85.23A2026-07-29
04046826531478Medicon68.85.21A68.85.21A2026-07-29
04046826531485Medicon68.85.22A68.85.22A2026-07-29
04046826561741Medicon68.93.04A68.93.04A2026-07-29
04046826531454Medicon68.85.19A68.85.19A2026-07-28
04046826110833Medicon66.27.5366.27.532026-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417116MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776417123MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776426613MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776426620MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776417017MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776417024MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776417031MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776425876MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776426453MillenniumAvalign Technologies, Inc.GAD2026-08-18
00198506093876ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093883ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093890ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093906ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093913ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093920ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093968ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093999ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094019ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094026ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094033ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094040ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094125ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094132ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00810130207459MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207466MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207473MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207480MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207497MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207503MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207510MSIModern Surgical Instruments LLCGAD2026-08-18