FDA.report

Medicon

Primary DI
04046826346379
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.85.86A
Catalog number
68.85.86A
Device description
Ti Micro cross slot screw 1.5x6.0mm green self-dril p/10
Published
2017-05-31
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
true

Related Records

Contact Domains

Product Codes

CodeName
JEYPLATE, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826346379PrimaryGS10
04046826346362Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826346379040468263463794046826346379
04046826346362040468263463624046826346362

GMDN Terms

TermDefinition
Craniofacial bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
10
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 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
00888118149671LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149701LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149718LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149725LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149732LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149749LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149756LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149763LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149770LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149787LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149794LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149800LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149817LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149824LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149831LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149848LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149855LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149879LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149886LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149893LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149909LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149916LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149923LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149930LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149947LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149954LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149961LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149978LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149985LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118153128LEVEL ONE NEURO, STERILEKLS-Martin L.P.JEY2026-03-23