DEVICE: Medicon (04046826371579)
Device Identifier (DI) Information
Medicon
68.93.52
In Commercial Distribution
68.93.52
Medicon eG. Chirurgiemechaniker-Genossenschaft
68.93.52
In Commercial Distribution
68.93.52
Medicon eG. Chirurgiemechaniker-Genossenschaft
Ti Micro plate 6 holes double Y Low Prof USA p/5
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Craniofacial fixation plate, non-bioabsorbable | A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JEY | PLATE, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bc63292b-4da9-49e4-94a5-5c7a42c1acbc
March 29, 2018
2
October 30, 2015
March 29, 2018
2
October 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046826371142
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+490746220090
sales@medicon.de
sales@medicon.de