FDA.report

Medicon

Primary DI
04046826125417
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
68.86.91
Catalog number
68.86.91
Device description
Ti Micro Mesh plate 67x82x0.1mm
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
04046826125417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826125417040468261254174046826125417

GMDN Terms

TermDefinition
Extra-gynaecological surgical mesh, metalA non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. It is constructed of cross-linked collagen (e.g., with glutaraldehyde). Disposable devices associated with implantation may be supplied with the mesh.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
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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00888118149671LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
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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
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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
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