FDA.report

Medicon

Primary DI
04046826484972
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.94.74A
Catalog number
68.94.74A
Device description
Ti Mini cross slot screw p/10 2x13 grey self-tapp fine thr.
Published
2021-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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
04046826484989PrimaryGS10
04046826484972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826484989040468264849894046826484989
04046826484972040468264849724046826484972

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

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