FDA.report

Medicon

Primary DI
04046826433918
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.85.87A
Catalog number
68.85.87A
Device description
Ti Micro cross slot screw 1.5x7.0mm green self-dril p/10
Published
2015-10-30
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
04046826433918PrimaryGS10
04046826433901Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826433918040468264339184046826433918
04046826433901040468264339014046826433901

GMDN Terms

TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted 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
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

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