FDA.reportPublic FDA data

Medicon

Primary DI
04046826531454
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.85.19A
Catalog number
68.85.19A
Device description
Ti Micro cross slot screw p/10 1.5x9 grey self-tapp fine thr.
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826531454PrimaryGS10
04046826531171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826531454040468265314544046826531454
04046826531171040468265311714046826531171

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It 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 titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

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
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 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
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
04046826486631Stern-a-Fix Sternal Closure System54.81.0854.81.082026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826486228MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531478MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531485MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826561741MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
05420060381041TruMatchMaterialise NVJEY2020-03-16
10888118113600LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
10888118113617LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
05420060380150TruMatchMaterialise NVJEY2017-08-31
05420060380174TruMatchMaterialise NVJEY2017-08-31
05420060381034TruMatchMaterialise NVJEY2017-08-31
05420060351112ProPlan CMFMaterialise NVJEY2016-09-15
05420060351013ProPlan CMFMaterialise NVJEY2016-09-13
05420060351020ProPlan CMFMaterialise NVJEY2016-09-13
05420060351044ProPlan CMFMaterialise NVJEY2016-09-13
05420060351051ProPlan CMFMaterialise NVJEY2016-09-13
05420060351068ProPlan CMFMaterialise NVJEY2016-09-13
05420060351075ProPlan CMFMaterialise NVJEY2016-09-13
00888118001825LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118001870LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002129LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24